|Year : 2021 | Volume
| Issue : 4 | Page : 456-463
Whole-body vibration, in addition to balance exercise, shows positive effects for strength and functional ability in patients with diabetic peripheral neuropathy: A single-blind randomized controlled trial
Aatika Waheed1, Muhammad Azharuddin1, Irshad Ahmad2, Majumi M Noohu1
1 Center for Physiotherapy and Rehabilitation Sciences, Jamia Millia Islamia, New Delhi, India
2 Department of Physiotherapy, Manav Rachna International Institute of Research and Studies, Faridabad, Haryana, India
|Date of Submission||14-Apr-2021|
|Date of Decision||25-May-2021|
|Date of Acceptance||04-Jun-2021|
|Date of Web Publication||12-Jan-2022|
Dr. Irshad Ahmad
Department of Physiotherapy, Manav Rachna International Institute of Research and Studies, Faridabad, Haryana.
Source of Support: None, Conflict of Interest: None
Purpose: The aim of the study was to evaluate the effect of whole-body vibration (WBV) with balance training on strength and functional ability in patients with diabetic peripheral neuropathy (DPN). Materials and Methods: Forty (19 males and 21 females) patients with DPN participated in the study. The patients were randomly allocated to experimental group (age = 57.3 ± 7.3) and control group (age = 57.1 ± 6.5). The experimental group performed WBV with balance training, whereas the control group performed only balance exercises for three weeks (five days/week). Outcome measures included neuropathy disability score (NDS), numeric pain rating scale (NPRS), timed up and go test (TUGT), Tinetti performance-oriented mobility assessment (Tinetti POMA) scale, strength of quadriceps, and tibialis anterior and reaction time. Results: Demographic characteristics and outcome measures at baseline were found to be nonsignificant between the groups. NDS, Tinetti POMA, quadriceps, and tibialis anterior strength showed significant time effect (P ≤ 0.016) and time × group interaction (P ≤ 0.008) whereas group effect was found to be nonsignificant. TUGT only showed significant time effect (P < 0.001). NPRS and reaction time showed significant time × group interaction (P ≤ 0.002). Conclusion: The WBV with balance exercise showed improvement in the NDS, functional balance, functional mobility, and strength of the lower limb muscles when compared with balance exercises only.
Keywords: Balance, disability, muscle strength, pain, reaction time
|How to cite this article:|
Waheed A, Azharuddin M, Ahmad I, Noohu MM. Whole-body vibration, in addition to balance exercise, shows positive effects for strength and functional ability in patients with diabetic peripheral neuropathy: A single-blind randomized controlled trial. J Diabetol 2021;12:456-63
|How to cite this URL:|
Waheed A, Azharuddin M, Ahmad I, Noohu MM. Whole-body vibration, in addition to balance exercise, shows positive effects for strength and functional ability in patients with diabetic peripheral neuropathy: A single-blind randomized controlled trial. J Diabetol [serial online] 2021 [cited 2022 Aug 13];12:456-63. Available from: https://www.journalofdiabetology.org/text.asp?2021/12/4/456/335612
| Introduction|| |
Peripheral neuropathy is a frequent complication of diabetes mellitus (DM). Diabetic peripheral neuropathy (DPN) affects as many as 36% of people with type 2 DM.,, DPN is associated with a reduction or loss of sensory-motor function, which can affect quality of life; result in impairment in balance and gait,, reduced muscle strength around the knee and ankle joints,, and increased reaction time; and aggravate the risk of falls. Fall or fall-related injuries increase immobility and dependency in activities of daily living, thereby deteriorating body function.,
Various balance training interventions are considered to be effective in improving balance. Regular exercise has been shown to improve balance, decrease postural sway, decrease reaction time, and increase muscle strength,,, and a good adjunct to therapeutic intervention to further improve balance and muscle strength is whole-body vibration (WBV). The WBV is very convenient and easy to use, and it shows a beneficial response in healthy and aging populations.,, Evidence also indicates that WBV has significant effects on muscle performance by increasing strength in patients with different disabilities.,
In WBV, the entire body is exposed to mechanical vibrations, producing neuromuscular activation of the leg musculature structure. Yoosefinejad, et al. found improved results for tibialis anterior strength and timed up and go test (TUGT) after a single session of WBV. In their pilot study, Stambolieva, et al. showed that eight weeks of plantar vibratory stimulation improves pain, tingling, and weakness in patients with DPN. A randomized controlled trial showed that WBV showed beneficial effects on pain, balance, and quality of life in patients with painful DPN. Another case study by Yoosefinejad, et al. showed enhanced electromyographical signals immediately after the application of WBV. With respect to balance, a study showed improved glycosylated hemoglobin (HbA1c), static and dynamic balance, and muscle strength in elderly DPN after WBV training in combination with balance exercise. There is a little higher level of evidence that shows an improvement in balance and strength after short-term intervention of WBV. Also, there is a lack of research showing its effect on the functional mobility of patients with DPN.
Therefore, the present study investigated the effect of three weeks of WBV with balance exercise on pain, neuropathy disability score (NDS), balance, functional mobility, muscle strength, and reaction time in individuals with DPN. We hypothesized that WBV along with balance exercise intervention will show greater improvement in these outcome measures when compared with only balance exercise programs.
| Materials and Methods|| |
Sample size calculation
The number of subjects was determined through G*Power 126.96.36.199, using the changes in the TUGT after six weeks (three days/week), that is, totally 18 sessions of WBV with balance exercises done by Lee, et al. A total of 40 subjects (including 15% dropouts) were shown to be necessary based on the two-tailed test, with an effect size of 1.19, an alpha level of 0.05, and power (1 − β) of 0.92.
Forty patients, aged between 50 and 70 years, were recruited for the study. Inclusion criteria were prediagnosed DPN (type II or type I DM) subjects having distal symmetrical sensory-motor polyneuropathy predominantly in the lower extremities with or without pain; NDS ≥3; Michigan neuropathy screening instrument (MNSI) questionnaire score ≥3; and ability to walk independently. Exclusion criteria were mini-mental state examination score ≤24; numeric pain rating scale (NPRS) >4; presence of moderate to severe musculoskeletal impairment in lower limbs; any other neurological pathology; any episode of plantar ulceration; and partial or total amputation.
Patients were recruited from (a) Diabetic Centre, Ansari Health Centre, Jamia Millia Islamia (JMI); (b) Outpatient Department, Centre for Physiotherapy and Rehabilitation Sciences (CPRS), JMI. Each patient was explained about the experimental protocols, procedures, and possible risks. Ethical clearance was obtained from the Institutional Ethics Committee, JMI, New Delhi, India. All patients were provided written informed consent before enrollment in the study.
The study was a two-arm, parallel-group randomized controlled trial with single blinding (blinding of outcome assessor). Patients who met the inclusion and exclusion criteria were randomly allocated to either of the two groups through block randomization with two block size and an allocation ratio 1:1 using a list of randomly generated numbers. The subjects allocated in the experimental group received WBV with balance exercise and dietary advice; the control group received balance exercise and dietary advice. Both groups were assessed at baseline and after three weeks of training. Enrollment and assignment of subjects were done by an investigator who was a part of neither the assessment of outcome measures nor the implementation of exercise or WBV or education. Study design is presented in [Figure 1]. This trial was designed in accordance with the Consolidated Standards of Reporting Trials statement.
All subjects (experimental and control groups) underwent a balance exercise program. The exercise was conducted for three weeks (five times/week), that is, totally 15 sessions. Each session of exercise comprised 10 min of warm-up, 40 min of balance exercise, and 5 min of cool-down. Warm-up included treadmill walking or cycling on ergometer. Balance exercise comprised two sets of sit to stand, one leg stance, tandem stance, wobble board exercise, and 300 squats. The first set of exercises was executed on a stable surface, whereas the second set of exercises was performed on an unstable surface by using Thera band® stability trainer. Each set of each exercise was performed for 3 min, with 1–2 min of rest in between the exercises. Cool-down included deep breathing, abdominal breathing, and mild stretching.
Dietary advice was conducted once in a week for 20 min. Dietary advice was given to each subject by professional physiotherapists specialized in DM. Educational leaflets were also provided to the patients.
The WBV training was performed by subjects in the experimental group, on a vibration platform (KH 75 Crazy Fit, VIVA Fitness, India). Training was carried out by each subject under the supervision of a researcher. Subjects were asked to stand barefoot on the vibratory platform with an even distribution of weight on both feet and familiarized with WBV at a lesser frequency and amplitude. Then, they were asked to bend their knee 30º to the vertical; thereafter, to obtain a greater muscular response, WBV training was performed at a frequency of 30 Hz and an amplitude of 2 mm. The exercise comprised five bouts of a 30-sec vibration with a 1-min elapse between the bouts.
Training was given to each subject individually under the supervision of a physiotherapist who had experience in dealing with patients with DPN. All the exercises and WBV training were given in the gymnasium of CPRS, JMI.
The MNSI comprises scoring on a self-administered questionnaire with 15 questions and five bilateral lower limb examinations, wherein the maximum score for the questionnaire score can be 13 points, whereas the lower limb examination can have a maximum score of 10 points. Questionnaire score >2.03 showed 38% sensitivity and 96% specificity, examination score >1.95 showed 45% sensitivity and 87% specificity, and a combination of both scores >3.25 showed 50% sensitivity and 92% specificity for confirmed clinical neuropathy.
The NDS consists of vibration perception (with 128 Hz tuning fork), pinprick and temperature perceptions in the great toe, and the presence or absence of ankle reflexes. The sensory modalities were scored as either present (0) or reduced or absent (1) for each leg; ankle reflexes were scored as normal (0), present with reinforcement (1), or absent (2) for each leg. The total maximal abnormal score was 10. The NDS is a simple, acceptable, reproducible, and validated tool for measuring DPN. The NDS has been found to have a strong correlation with glycemic control compared with vibration perception thresholds.
NPRS was used to record pain. It is a valid and reliable scale for recording subjective pain intensity. Subjects were asked to rate their pain intensity on a scale of 0 (no pain) to 10 (worst pain). The subjects gave three pain ratings, corresponding to current, best, and worst pain experienced over the past 24 h. The average of the three ratings was calculated for the level of pain over the previous 24 h.
The TUGT is used to examine functional mobility in community-dwelling, frail older adults. The subjects were asked to get up from the chair on the word “go,” walk a pre-marked distance of 3 m at a comfortable and safe speed, turn around, and come back and sit again on the chair. The time taken to perform the test was recorded in seconds. An average of three scores was used for the analysis. The TUGT has good intra-rater and inter-rater reliability.,
The Tinetti performance-oriented mobility assessment (Tinetti POMA) scale consists of nine balance and seven gait tasks performed by each subject. Balance and gait components are scored 0–1 and 0–2, respectively. The maximum score for balance is 16 and for gait it is 12 (total = 28). In a study of the inter-rater reliability of POMA, kappa coefficients of 0.40–0.75 were found across raters of varied experience, indicating fair to good reliability.
Muscle strength was evaluated for two muscles of the dominant limb: quadriceps femoris and tibialis anterior by using hand held dynamometry (model No. 01165, Lafayette MMT System, USA). To evaluate quadriceps muscle strength, the patients were positioned in the prone position, lying with the knee flexed to 900; the dynamometer was fixed proximal to the ankle on the anterior surface of the leg; and the subjects were asked to perform isometric knee extension. To evaluate tibialis anterior strength, patients were asked to lie supine with their ankles at the edge of the plinth. The ankle joints were placed in the neutral position (between dorsiflexion and plantar flexion). The dynamometer was fixed to the dorsal aspect of the foot, and each subject was asked to perform isometric dorsiflexion. The thigh of the dominant limb, leg of the nondominant limb, and the trunk were stabilized by using belts. Three maximal isometric contractions were recorded, and the average of three trials was used for analysis.
Reaction time was evaluated by using Pedalo®-Sensamove Balance Test Pro with Miniboard. The subjects were asked to stand on the device with a display screen at eye level, and they were instructed to hold the center of pressure. They were asked to touch the spot as soon as it appeared on the screen with their displayed center of pressure. The time (in seconds) taken to reach the spot in the front, back, left, and right directions was recorded. The average of all directions was used for analysis. The reliability of the device for reaction time has been previously reported in older subjects with ICC value 0.79.
Thirty-eight subjects were included for the analysis. The normality of distribution of all variables was verified using Shapiro-Wilk test. A nonparametric test was used for the measures that showed non-normal distribution. Demographic characteristics and baseline measures were compared by using independent t-test or Mann-Whitney U test. A 2 × 2 mixed ANOVA was used to find out the main effect (group and time effects) and time × group interaction for NDS, TUGT, Tinetti POMA, quadriceps strength, tibialis anterior strength, and reaction time. Level of significance was set at P ≤ 0.05, and confidence interval was set at 95%. All statistical analysis was done using SPSS version 21.
| Results|| |
One patient from each group was lost (early dropout) during the follow-up; 38 subjects completed the study protocol. Statistical analysis was done for 19 patients in each group. The demographic characteristics of subjects are mentioned in [Table 1]. Demographic characteristics such as age, height, weight, BMI, duration of disease, HbA1c, mini-mental state examination score, and MNSI score showed no significant difference between the groups (P > 0.05). Outcome variables such as NPRS, NDS, TUGT, Tinetti POMA score, strength of quadriceps and tibialis anterior, and reaction time showed no significant differences between the groups at baseline (P > 0.05).
|Table 1: Demographic characteristics and baseline measurement of outcome measures|
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The mean ± SD of the baseline and post-intervention values of outcome measures is shown in [Table 2]. The NDS was found to be significant time effect (P < 0.001) and time × group interaction (P < 0.001), whereas the group effect (P = 0.847) was found to be nonsignificant. There was a significant time effect and time × group interaction for Tinetti POMA score (P < 001 and P < 0.001, respectively), quadriceps strength (P = 0.011 and P < 0.001, respectively), and tibialis anterior strength (P = 0.016 and P < 0.001, respectively) whereas group effect was found to be nonsignificant [Table 2]. The TUGT showed a significant time effect (P < 0.001), whereas group effect and time × group interaction were found to be nonsignificant. The NPRS and reaction time showed a nonsignificant time and group effect, whereas time × group interaction was found to be significant (P ≤ 0.002) [Table 2].
| Discussion|| |
This study revealed that three weeks of WBV along with balance exercise intervention result in an improvement of neuropathy score, balance measures, and quadriceps and tibialis anterior strength when compared with balance exercise only.
Previous research shows a reduction in pain and tingling sensation after WBV training. Kessler and Hong also showed a reduction in chronic neuropathic pain with a visual analog pain scale in both lower limbs after four weeks of WBV. Jamal, et al. also found a decrease in neuropathic pain after six weeks of WBV in patients with painful DPN. This study also found similar results showing a reduction in the NPRS score after WBV plus balance exercise in comparison with balance exercise only. The present study found a larger decrease in NDS score after WBV and balance exercise training (21.25%) when compared with the balance exercise only group (0.99%). The NDS score is used to grade the severity of neuropathy, which includes an assessment of sensation and reflexes. Although improvement in glycemic control could be a reason for improvement in NDS, this study does not directly measure glycemic control. According to a previous study, the NDS has been found to be significantly correlated with HbA1c. Lee, et al. found that WBV plus balance exercise showed a decrease in HbA1c when compared with the balance exercise only or control group. Improvement in nerve conduction velocity could be another reason for changes in the NDS score. A pilot study showed that plantar vibration improves sural sensory nerve conduction velocity in both the lower limbs, and nerve conduction studies found a good association with the NDS score.
Our study found similar improvement in the TUGT in both groups, which is in contrast with previous studies, indicating that WBV plus balance exercise results in greater improvement than balance exercise only. The reason for this could be the duration of the protocol (six weeks) and the frequency of WBV applied by Lee, et al., which progressed weekly from 15Hz to 30Hz and in amplitude from 1 to 3 mm. The present study prescribed WBV at 30Hz frequency and 2 mm amplitude for three weeks. Yoosefinejad, et al. found improvement in TUGT after six weeks of WBV when compared with the control. Our study also found a 12.17% increase in the Tinetti POMA score after WBV plus the balance exercise program, indicating improvement in balance and gait characteristics, which is similar to previous studies. Lee, et al. found improvement in Berg balance scale and postural sway after WBV plus balance exercise when compared with the balance exercise or control group. Yoosefinejad, et al. and Stambolieva, et al. also found improvement in the clinical measures of balance and postural sway after WBV training.,
A known fact is that balance and gait impairment in the DPN population is primarily due to the loss/reduction of peripheral somatosensory and proprioceptive sensation. Proprioception includes sensations from soft tissues around the joint and joint capsule, whereas somatosensory includes sensations of touch, pressure, and vibration. The WBV gives mechanical vibration, which stimulates the mechanoreceptors of the skin, muscles joints around the foot and ankle joint. Mechanical vibration also activates muscle spindles via Ia afferents and motor efferent fibers, which is helpful in the alteration of proprioception and in improving Tinetti POMA score. The WBV showed improvement in the proprioception of female patients with knee osteoarthritis. According to Stambolieva, et al., mechanical vibration also improves tactile sensation by improving signals and transmission of senses. Further research is required to discover the actual pathway for the improvement in balance measures.
The present study also found an increase in the muscle strength of quadriceps and tibialis anterior in the WBV plus the balance exercise group, when compared with the balance exercise only group. Yoosefinejad, et al. found an increase in the muscle strength of quadriceps and tibialis anterior, using a dynamometer, after the immediate application of WBV. They stated that the increase in muscle contractibility was due to the “tonic vibratory reflex,” which is based on the activation of muscle spindles via Ia afferent neural stimulation, which leads to a temporary increase in the muscle force. Six weeks of WBV training increased quadriceps and tibialis anterior strength. Lee, et al. also found greater improvement in muscle strength using five time sit to stance in WBV plus balance exercise, when compared with the balance exercise or control group. These results were similar to our study. A mechanism that emphasizes the increase in muscle strength is the “muscle tuning hypothesis” given by Abercromby, et al., which states that there is a body strategy that increases the high level of muscle contraction to damp mechanical vibration energy transmitted from the vibratory platform; these muscles that are closer to the resonance cause higher activation. This is in line with the present study, which found a greater change in the tibialis anterior (90.01 ± 18 to 93.9 ± 19.56) than quadriceps (102.6 ± 15.19 to 104.02 ± 14.93). Although previous studies showed that quadriceps strength increased due to the squatting posture acquired during WBV stimulation,, muscle strength enhancement can also be attributed to the simulation of postactivation potentiation after each bout of vibration induced muscle contraction, indicating that there was rapidly eccentric and concentric muscle contraction due to WBV.
This study had a few limitations. The study did not include long-term follow-up after intervention. Another limitation was that the sample size was small. Also, our study comprised subjects with primarily mild to moderate neuropathy. Future research could focus on the effect of WBV on the muscle activation pattern and nerve function depending on different levels of neuropathy. Also, the effect of WBV with balance exercise can be assessed by using a different frequency of intervention (days/week), considering a similar volume of intervention.
| Conclusion|| |
The WBV with balance exercise showed superior benefits on the NDS, functional balance measures, and muscle strength of the lower limb muscles. The WBV should, thus, be incorporated with balance exercises, which are considered an effective treatment for fall prevention. We believe that it may be a suitable adjunct therapeutic intervention, along with glycemic control, for patients with DPN.
The authors express their deep gratitude to the participants for their enthusiasm and willingness to participate in this study.
Financial support and sponsorship
The present study was supported by Jamia Millia Islamia (a central university), New Delhi, India.
Conflicts of interest
There are no conflicts of interest.
Study concept and design: Aatika Waheed and Muhammed Azharuddin. Enrollment and assignment of subjects: Majumi M. Noohu. Acquisition of data: Aatika Waheed and Irshad Ahmad. Analysis and interpretation of data: Irshad Ahmad and Majumi M. Noohu. Drafting of the article: Aatika Waheed, Muhammed Azharuddin, and Irshad Ahmad. Critical revision of the article for important intellectual content: Irshad Ahmad and Majumi M. Noohu. Administrative, technical, and material support: Majumi M. Noohu. Study supervision: Muhammed Azharuddin and Irshad Ahmad.
Ethical approval was obtained from the Institutional Ethics Committee, Jamia Millia Islamia, New Delhi, India, prior to the conducting of the study procedure.
All the subjects have signed the complete informed consent form for scientific research.
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[Table 1], [Table 2]