Diabetic Peripheral Neuropathy (DPN)MSTNCT07096570
Multi-Sensory Training for Balance, EMG, Sensory Deficits in DPN
A study testing Selected Multisensory Training (SMST) in people with Diabetic Peripheral Neuropathy (DPN), run by Monireh Asadi Ghaleni at 1 site in Iran.
Trial summary
This study evaluated whether a 12-week multisensory training program could improve movement control, balance, and sensory function in women with diabetic peripheral neuropathy (DPN). Nineteen women aged around 68 years were randomly assigned to either a training group or a control group. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Diabetic Peripheral Neuropathy (DPN)
- What is being tested?
- Selected Multisensory Training (SMST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteIran
- Study dates
- 25 Mar 2025to 22 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- Age 60 years or older
- Clinical diagnosis of diabetic peripheral neuropathy (DPN)
- Ability to stand unaided for at least 10 minutes
- Mini-Mental State Examination (MMSE) score ≥ 24
- Ability to walk at least 20 meters unassisted
- Diabetes duration of at least 10 years
- Normal or corrected-to-normal vision
Who cannot join
- Structural damage to lower extremities that affects balance or gait
- Severe neuropathy or other neurological disorders aside from DPN
- Cognitive impairment (MMSE score < 24)
- Any condition limiting participation in exercise (e.g., severe cardiovascular disease, recent fractures)
- Use of medications that significantly affect balance or neuromuscular function beyond typical diabetic treatment
- Participation in other structured exercise or balance training programs during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Multi-Sensory Training on sEMG Activity in Lower-Limb Muscles, Balance, and Sensory Function in Patients With Diabetic Neuropathy: A Randomized Controlled Trial
This study evaluated whether a 12-week multisensory training program could improve movement control, balance, and sensory function in women with diabetic peripheral neuropathy (DPN). Nineteen women aged around 68 years were randomly assigned to either a training group or a control group. The training group participated in supervised sessions twice a week for 12 weeks. Before and after the intervention, several measures were taken, including muscle activity, balance tests, and sensory perception tests.
Read the detailed description
Introduction Diabetes mellitus is a group of chronic metabolic disorders characterized by persistent hyperglycemia due to defects in insulin secretion, insulin action, or both(1).
With the world's population aged over 60 projected to increase from 12% to 22% between 2015 and 2050, the burden of diabetes among the elderly is expected to rise substantially. In Iran, the prevalence of diabetes in individuals over 65 is estimated to reach 6.5 million by 2030, and approximately 53% of type 2 diabetic patients develop peripheral neuropathy(2, 3).
Diabetic peripheral neuropathy (DPN) is a progressive neurodegenerative disorder involving both peripheral nerve damage and maladaptive central sensory processing(4). This dual pathology impairs the integration of vestibular, visual, and proprioceptive inputs critical for postural stabilit (5). Older adults with DPN exhibit increased postural sway and higher fall incidence compared to their non-neuropathic counterparts(6, 7). Damage to large-diameter afferent fibers and microangiopathic nerve alterations further disrupt joint proprioception, resulting in impaired anticipatory and compensatory postural adjustments(8).
Given these challenges, targeted interventions are crucial to mitigate fall risk and enhance functional outcomes in this vulnerable population(9). In addition to sensory deficits, muscle weakness-particularly a 17% reduction in ankle dorsiflexor strength and a 14% decrease in plantarflexor strength-further compromises postural stability and increases fall risk among DPN patients(8). Recent evidence demonstrates that focused strength training and neuromuscular rehabilitation can significantly improve postural control and reduce fall incidence in this population(10).
Exercise-based interventions-including whole-body vibration training(11), vestibular exercises(12), lower-limb strength training(13), and ankle-strategy drills(14) - have demonstrated significant benefits for balance and neuromuscular function. However, most protocols target only a single sensory modality and may not adequately address the multisystem impairments characteristic of DPN(12, 15, 16). Emerging evidence indicates that combined multisensory or sensorimotor-gait training can improve proprioception, nerve function, and muscle activation in DPN patients (17). Notably, Ahmad et al. (2020) reported in a randomized controlled trial that an 8-week sensorimotor and gait training program significantly enhanced proprioception, nerve conduction velocity, and muscle activation-particularly in the medial gastrocnemius and multifidus-during postural tasks and gait in DPN patients(17). Similarly, Malwanage et al. (2024) found that a 12-week ankle-focused proprioceptive training program significantly improved ankle reaction strategies and postural stability (18). Despite these promising results, no study has specifically investigated the effects of a structured 12-week selected multisensory training on neuromuscular activation and sensory function in older women with DPN-a population at particularly high risk of falls. Targeting multisensory integration pathways may offer novel neurorehabilitative strategies to counteract CNS maladaptation in DPN.
However, no prior randomized controlled Trial has concurrently examined neuromuscular activation, balance, and cutaneous sensitivity following a multisensory training program in elderly women with DPN. Therefore, this study aims to investigate the effects of a 12-week selected multisensory training (SMST) intervention on EMG RMS amplitude of postural control muscles (semitendinosus, rectus femoris, lateral gastrocnemius, and tibialis anterior), along with performance on the stork balance test, Timed Up and Go (TUG) test, and two-point discrimination test in older women with diabetic peripheral neuropathy, compared to a control group. We hypothesize that SMST will significantly enhance neuromuscular activation patterns and balance performance, offering a comprehensive fall-prevention approach for this high-risk population.
Materials and Methods Study Design This randomized controlled trial employed pre-test and post-test assessments with a control group to evaluate the effects of a 12-week selected multisensory training (SMST) program on lower limb EMG activity, balance, and sensory function in older women with diabetic peripheral neuropathy (DPN). The study was conducted at Parsian Diabetes Clinic under the supervision of a board-certified neurologist. All data collection took place in a standardized laboratory environment to ensure measurement reliability. Participants received detailed information about the study objectives and procedures upon arrival, and written informed consent was obtained in compliance with ethical guidelines. Baseline demographic and clinical characteristics (including age, sex, diabetes duration, and neuropathy status) were recorded prior to testing. The study protocol received approval from the Research Ethics Committee of Damghan University (Approval ID: IR.DU.REC.a404.011) and adhered to the Declaration of Helsinki and relevant ethical standards.
Participants
In March 2025, thirty women aged ≥60 years with clinically diagnosed diabetic neuropathy (DN) from Mashhad were initially telephone-screened at 25 march 2025. nineteen eligible participants who met the inclusion criteria provided written informed consent for study participation (Figure 1):
- Female sex;
- Age ≥ 60 years;
- Ability to stand unaided for at least 10 minutes;
- No structural damage to the lower extremities;
- Mini-Mental State Examination (MMSE) score ≥ 24;
- Ability to walk 20 meters unassisted;
- At least 10 years' history of diabetes;
- Normal or corrected-to-normal vision. The severity of neuropathy among participants ranged from mild to moderate. All medications, including antidiabetic agents, antihypertensives, and analgesics, were monitored and documented under the supervision of a board-certified neurologist to assess potential impacts on study outcomes. Additionally, blood glucose levels were regularly monitored throughout the study to ensure adequate glycemic control. Participants were randomly allocated to either the SMST intervention group (n=10) or control group (n=9). The mean participant age was 62.21 ± 1.8 years. An independent researcher conducted randomization using a computer-generated sequence, with assignments concealed in sequentially numbered, opaque envelopes that were not reused after opening.
Intervention SMST Intervention
Participants in the SMST group completed two 40-minute supervised sessions weekly for 12 consecutive weeks in the University Rehabilitation Laboratory, conducted by a board-certified motor behavior specialist. The progressive-overload protocol increased exercise intensity by 5-10% every three weeks. Each session included:
- Warm-Up (5-8 minutes):
- Dynamic stretching targeting lower-limb joints and muscles
- Core Multisensory Training (25-30 minutes):
- Proprioceptive challenges: Static/dynamic balance exercises on progressively firmer foam surfaces (soft→medium→firm), performed with eyes open then closed
- Vestibular activation: Gait drills incorporating forward/backward/lateral walking with head turns, plus eyes-closed movements on unstable surfaces
- Visual tasks: Tracking moving visual targets during standing with controlled head movements
- Cool-Down (5 minutes):
- Seated breathing exercises with eyes closed
- Gentle lower-limb stretching
Progression Protocol:
- Biweekly intensity adjustments based on performance logs
- Progression methods: Increased surface instability, added handheld weights (1-2 lbs), reduced base of support, and transitioned from eyes-open to eyes-closed conditions
- Individual modifications and session adherence were documented to maintain intervention fidelity and appropriate challenge levels This structured SMST protocol provides concurrent vestibular, visual, and proprioceptive stimulation designed to improve neuromuscular activation patterns, as quantified by SEMG RMS measurements of key lower-limb muscles.
Control Group To control for social interaction effects, the control group participated in twice-weekly 40-minute unstructured group discussions with peers and staff while maintaining their usual activity levels and avoiding any new exercise regimens.
Outcome Measures Mini-Mental State Examination (MMSE) Cognitive function was assessed using the Mini-Mental State Examination (MMSE), a widely used dementia screening tool developed in 1975. The MMSE has a maximum total score of 30 points.(19).
Lower limb EMG:
Root mean square (RMS) amplitude of surface electromyography (sEMG) signals is a widely accepted biomarker for quantifying neuromuscular activation and muscle fatigue, offering critical insight into muscle function in DPN patients(7).
In this study, a surface EMG system (2000 Hz) was used to collect surface EMG data from 4 muscles of the right limb: semitendinosus, rectus femoris, lateral gastrocnemius, and tibialis anterior. Skin preparation included shaving, abrasion, and cleaning with alcohol to reduce impedance. Surface EMG signals were recorded using bipolar Ag/agcl electrodes placed per SENIAM guidelines (10 mm electrode diameter, 20 mm inter-electrode distance) on the midline of each muscle belly, oriented parallel to fiber direction.
The intercepted EMG data were preprocessed using Matlab r2022a, including mean removal, bandpass filtering (4th order Butterworth filter, 10-400 Hz), full-wave rectification, and smoothing using a low-pass filter. The low-pass filter applied for smoothing was a 4th-order Butterworth filter with a cut-off frequency of 20 Hz. This filter was designed to effectively remove high-frequency noise while preserving the relevant muscle signal characteristics. The 4th-order Butterworth filter was chosen to ensure a flat passband and a smooth roll-off at the cut-off frequency(20).
For each muscle, the peak root mean square (RMS) value calculated across 5 to 25 s time-series represented the maximal EMG activity as reference (RMSPEAK). The average of the RMS values (250 ms, 50% overlapped) from this same time-series portion was also computed, representing the mean RMS activity during balance (RMSTASK). Both RMSPEAK and RMSTASK were averaged across 2 trials and muscle activation (in %) was computed, as follows(21).
- RMS EMG = [(RMSTASK/RMSPEAK)×100% ]
Timed Up and Go (TUG) Test The Timed Up and Go (TUG) test was employed to assess both dynamic balance and functional mobility. Participants performed the test by standing from a chair, walking 3 meters, turning, returning to the chair, and sitting down. Each participant completed two trials, with the average time (in seconds) recorded for analysis(22). This average time also served as the single-task walking time for dual-task assessments. The TUG demonstrated excellent reliability (ICC >0.90) for participants with moderate neuropathy and good reliability (ICC 0.70-0.90) for those with severe neuropathy(23).
Single-Leg Stance Test Static balance was assessed using the Single-Leg Stance test. Participants stood on one leg with eyes open, maintaining the lifted foot without contact with the supporting limb or ground. The test continued for a maximum of 30 seconds or until termination due to: 1- contact between legs, 2- foot touching the floor, 3- hopping/jumping movements, or 4- use of external support - indicating balance impairment(24, 25). Research demonstrates that shorter single-leg stance times correlate with peripheral and cardiac autonomic nerve dysfunction as well as clinical neuropathy in type 2 diabetes patients, independent of age.(26).
Two-Point Discrimination (2PD) Test:
Sensory function was assessed using the Two-Point Discrimination (2PD) test. The 2PD threshold represents the minimum distance at which two simultaneous mechanical stimuli are perceived as distinct points. Testing was performed using a [brand/model name] two-point discriminator applied to the plantar surface of the foot. With eyes closed, participants verbally reported "one," "two," or "I can't tell" after each stimulus application (27).
Data Analysis All analyses adhered to the intention-to-treat principle, focusing exclusively on EMG RMS data. Between-group and longitudinal comparisons were conducted using repeated-measures ANOVA (α = 0.05) in SPSS version 26 (IBM Corp., Armonk, NY, USA).
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Being tested
- Selected Multisensory Training (SMST)
- Keywords
- Diabetic Peripheral Neuropathy, Multisensory Training, Electromyography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected Multisensory Training (SMST)Behavioural
A 12-week supervised exercise program involving two 40-minute sessions weekly. The program includes proprioceptive challenges on progressively firmer surfaces, vestibular activation with gait drills and head movements, and visual tracking tasks. Intensity progresses every three weeks by increasing surface instability, adding handheld weights, and reducing visual input (eyes open to eyes closed). The intervention aims to improve neuromuscular activation, balance, and sensory integration in older women with diabetic peripheral neuropathy.
| Study group | Role | What they receive |
|---|---|---|
| Selected Multisensory Training (SMST) Group | Experimental | Participants receive a 12-week supervised multisensory exercise program targeting balance, proprioception, and vestibular function. Receives: Behavioral: Selected Multisensory Training (SMST) |
| Control Group | No intervention | Participants engage in twice-weekly 40-minute unstructured group discussions without exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular Activation (EMG RMS Amplitude)
Root Mean Square (RMS) amplitude of surface electromyography (sEMG) signals recorded from semitendinosus, rectus femoris, lateral gastrocnemius, and tibialis anterior muscles during postural control tasks in older women with diabetic peripheral neuropathy.
Measured: Baseline and after 12 weeks
Secondary outcomes (3)
Balance Performance (Stork Balance Test)
Duration (in seconds) participants can maintain single-leg stance balance with eyes open, measured using the Stork Balance Test.
Measured: Baseline and after 12 weeks
Functional Mobility (Timed Up and Go Test)
Time (in seconds) taken to stand up from a chair, walk 3 meters, turn, return, and sit down, assessing dynamic balance and mobility.
Measured: Baseline and after 12 weeks
sensory Function (Two-Point Discrimination Test)
Baseline and after 12 weeks
Measured: Minimum distance at which participants can distinguish two points on the plantar surface of the foot, measuring cutaneous sensory discrimination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start25 Mar 2025
- Primary completion21 Apr 2025
- Study completion22 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetic Peripheral Neuropathy (DPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Monireh Asadi Ghaleni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Monireh Asadi Ghaleni, Alzahra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096570
- Sponsor's protocol ID
- IR.DU.REC.a404.011
- Acronym
- MST
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mofateh R, Rahimzadeh S. The effects of multisensory exercises on balance control in people with diabetic peripheral neuropathy: a narrative review. Practical Diabetes. 2024;41(4):35-41. https://doi.org/10.1002/pdi.2522
Kutty NAM, Majida NAL. Effects of multisensory training on balance and gait in persons with type 2 diabetes: a randomised controlled trial. Disability, CBR & Inclusive Development. 2013;24(2):79-91. https://doi.org/10.5463/dcid.v24i2.206
Ahmad I, Verma S, Noohu MM, Shareef MY, Hussain ME. Sensorimotor and gait training improves proprioception, nerve function, and muscular activation in patients with diabetic peripheral neuropathy: a randomized control trial. J Musculoskelet Neuronal Interact. 2020 Jun 1;20(2):234-248.
PubMed 32481239Asadi Ghaleni M, Sohrabi M, Taheri HR, Homam M. Effect of a multi-sensory training program on the balance of older women with diabetic peripheral neuropathy: a randomized controlled trial. The Scientific Journal of Rehabilitation Medicine. 2022;11(1):154-167. doi:10.32598/SJRM.11.1.10
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multi-Sensory Training on sEMG Activity in Lower-Limb Muscles, Balance, and Sensory Function in Patients With Diabetic Neuropathy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07096570
- Acronym / sponsor ID
- MST / IR.DU.REC.a404.011
- Conditions
- Diabetic Peripheral Neuropathy (DPN)
- Keywords
- Diabetic Peripheral Neuropathy, Multisensory Training, Electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Monireh Asadi GhaleniUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 21 Apr 2025 (actual)
- Study completion
- 22 Jun 2025 (actual)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated whether a 12-week multisensory training program could improve movement control, balance, and sensory function in women with diabetic peripheral neuropathy (DPN). Nineteen women aged around 68 years were randomly assigned to either a training group or a control group. The training group participated in supervised sessions twice a week for 12 weeks. Before and after the intervention, several measures were taken, including muscle activity, balance tests, and sensory perception tests.
Detailed description
Introduction Diabetes mellitus is a group of chronic metabolic disorders characterized by persistent hyperglycemia due to defects in insulin secretion, insulin action, or both(1).
With the world's population aged over 60 projected to increase from 12% to 22% between 2015 and 2050, the burden of diabetes among the elderly is expected to rise substantially. In Iran, the prevalence of diabetes in individuals over 65 is estimated to reach 6.5 million by 2030, and approximately 53% of type 2 diabetic patients develop peripheral neuropathy(2, 3).
Diabetic peripheral neuropathy (DPN) is a progressive neurodegenerative disorder involving both peripheral nerve damage and maladaptive central sensory processing(4). This dual pathology impairs the integration of vestibular, visual, and proprioceptive inputs critical for postural stabilit (5). Older adults with DPN exhibit increased postural sway and higher fall incidence compared to their non-neuropathic counterparts(6, 7). Damage to large-diameter afferent fibers and microangiopathic nerve alterations further disrupt joint proprioception, resulting in impaired anticipatory and compensatory postural adjustments(8).
Given these challenges, targeted interventions are crucial to mitigate fall risk and enhance functional outcomes in this vulnerable population(9). In addition to sensory deficits, muscle weakness-particularly a 17% reduction in ankle dorsiflexor strength and a 14% decrease in plantarflexor strength-further compromises postural stability and increases fall risk among DPN patients(8). Recent evidence demonstrates that focused strength training and neuromuscular rehabilitation can significantly improve postural control and reduce fall incidence in this population(10).
Exercise-based interventions-including whole-body vibration training(11), vestibular exercises(12), lower-limb strength training(13), and ankle-strategy drills(14) - have demonstrated significant benefits for balance and neuromuscular function. However, most protocols target only a single sensory modality and may not adequately address the multisystem impairments characteristic of DPN(12, 15, 16). Emerging evidence indicates that combined multisensory or sensorimotor-gait training can improve proprioception, nerve function, and muscle activation in DPN patients (17). Notably, Ahmad et al. (2020) reported in a randomized controlled trial that an 8-week sensorimotor and gait training program significantly enhanced proprioception, nerve conduction velocity, and muscle activation-particularly in the medial gastrocnemius and multifidus-during postural tasks and gait in DPN patients(17). Similarly, Malwanage et al. (2024) found that a 12-week ankle-focused proprioceptive training program significantly improved ankle reaction strategies and postural stability (18). Despite these promising results, no study has specifically investigated the effects of a structured 12-week selected multisensory training on neuromuscular activation and sensory function in older women with DPN-a population at particularly high risk of falls. Targeting multisensory integration pathways may offer novel neurorehabilitative strategies to counteract CNS maladaptation in DPN.
However, no prior randomized controlled Trial has concurrently examined neuromuscular activation, balance, and cutaneous sensitivity following a multisensory training program in elderly women with DPN. Therefore, this study aims to investigate the effects of a 12-week selected multisensory training (SMST) intervention on EMG RMS amplitude of postural control muscles (semitendinosus, rectus femoris, lateral gastrocnemius, and tibialis anterior), along with performance on the stork balance test, Timed Up and Go (TUG) test, and two-point discrimination test in older women with diabetic peripheral neuropathy, compared to a control group. We hypothesize that SMST will significantly enhance neuromuscular activation patterns and balance performance, offering a comprehensive fall-prevention approach for this high-risk population.
Materials and Methods Study Design This randomized controlled trial employed pre-test and post-test assessments with a control group to evaluate the effects of a 12-week selected multisensory training (SMST) program on lower limb EMG activity, balance, and sensory function in older women with diabetic peripheral neuropathy (DPN). The study was conducted at Parsian Diabetes Clinic under the supervision of a board-certified neurologist. All data collection took place in a standardized laboratory environment to ensure measurement reliability. Participants received detailed information about the study objectives and procedures upon arrival, and written informed consent was obtained in compliance with ethical guidelines. Baseline demographic and clinical characteristics (including age, sex, diabetes duration, and neuropathy status) were recorded prior to testing. The study protocol received approval from the Research Ethics Committee of Damghan University (Approval ID: IR.DU.REC.a404.011) and adhered to the Declaration of Helsinki and relevant ethical standards.
Participants
In March 2025, thirty women aged ≥60 years with clinically diagnosed diabetic neuropathy (DN) from Mashhad were initially telephone-screened at 25 march 2025. nineteen eligible participants who met the inclusion criteria provided written informed consent for study participation (Figure 1):
- Female sex;
- Age ≥ 60 years;
- Ability to stand unaided for at least 10 minutes;
- No structural damage to the lower extremities;
- Mini-Mental State Examination (MMSE) score ≥ 24;
- Ability to walk 20 meters unassisted;
- At least 10 years' history of diabetes;
- Normal or corrected-to-normal vision. The severity of neuropathy among participants ranged from mild to moderate. All medications, including antidiabetic agents, antihypertensives, and analgesics, were monitored and documented under the supervision of a board-certified neurologist to assess potential impacts on study outcomes. Additionally, blood glucose levels were regularly monitored throughout the study to ensure adequate glycemic control. Participants were randomly allocated to either the SMST intervention group (n=10) or control group (n=9). The mean participant age was 62.21 ± 1.8 years. An independent researcher conducted randomization using a computer-generated sequence, with assignments concealed in sequentially numbered, opaque envelopes that were not reused after opening.
Intervention SMST Intervention
Participants in the SMST group completed two 40-minute supervised sessions weekly for 12 consecutive weeks in the University Rehabilitation Laboratory, conducted by a board-certified motor behavior specialist. The progressive-overload protocol increased exercise intensity by 5-10% every three weeks. Each session included:
- Warm-Up (5-8 minutes):
- Dynamic stretching targeting lower-limb joints and muscles
- Core Multisensory Training (25-30 minutes):
- Proprioceptive challenges: Static/dynamic balance exercises on progressively firmer foam surfaces (soft→medium→firm), performed with eyes open then closed
- Vestibular activation: Gait drills incorporating forward/backward/lateral walking with head turns, plus eyes-closed movements on unstable surfaces
- Visual tasks: Tracking moving visual targets during standing with controlled head movements
- Cool-Down (5 minutes):
- Seated breathing exercises with eyes closed
- Gentle lower-limb stretching
Progression Protocol:
- Biweekly intensity adjustments based on performance logs
- Progression methods: Increased surface instability, added handheld weights (1-2 lbs), reduced base of support, and transitioned from eyes-open to eyes-closed conditions
- Individual modifications and session adherence were documented to maintain intervention fidelity and appropriate challenge levels This structured SMST protocol provides concurrent vestibular, visual, and proprioceptive stimulation designed to improve neuromuscular activation patterns, as quantified by SEMG RMS measurements of key lower-limb muscles.
Control Group To control for social interaction effects, the control group participated in twice-weekly 40-minute unstructured group discussions with peers and staff while maintaining their usual activity levels and avoiding any new exercise regimens.
Outcome Measures Mini-Mental State Examination (MMSE) Cognitive function was assessed using the Mini-Mental State Examination (MMSE), a widely used dementia screening tool developed in 1975. The MMSE has a maximum total score of 30 points.(19).
Lower limb EMG:
Root mean square (RMS) amplitude of surface electromyography (sEMG) signals is a widely accepted biomarker for quantifying neuromuscular activation and muscle fatigue, offering critical insight into muscle function in DPN patients(7).
In this study, a surface EMG system (2000 Hz) was used to collect surface EMG data from 4 muscles of the right limb: semitendinosus, rectus femoris, lateral gastrocnemius, and tibialis anterior. Skin preparation included shaving, abrasion, and cleaning with alcohol to reduce impedance. Surface EMG signals were recorded using bipolar Ag/agcl electrodes placed per SENIAM guidelines (10 mm electrode diameter, 20 mm inter-electrode distance) on the midline of each muscle belly, oriented parallel to fiber direction.
The intercepted EMG data were preprocessed using Matlab r2022a, including mean removal, bandpass filtering (4th order Butterworth filter, 10-400 Hz), full-wave rectification, and smoothing using a low-pass filter. The low-pass filter applied for smoothing was a 4th-order Butterworth filter with a cut-off frequency of 20 Hz. This filter was designed to effectively remove high-frequency noise while preserving the relevant muscle signal characteristics. The 4th-order Butterworth filter was chosen to ensure a flat passband and a smooth roll-off at the cut-off frequency(20).
For each muscle, the peak root mean square (RMS) value calculated across 5 to 25 s time-series represented the maximal EMG activity as reference (RMSPEAK). The average of the RMS values (250 ms, 50% overlapped) from this same time-series portion was also computed, representing the mean RMS activity during balance (RMSTASK). Both RMSPEAK and RMSTASK were averaged across 2 trials and muscle activation (in %) was computed, as follows(21).
- RMS EMG = [(RMSTASK/RMSPEAK)×100% ]
Timed Up and Go (TUG) Test The Timed Up and Go (TUG) test was employed to assess both dynamic balance and functional mobility. Participants performed the test by standing from a chair, walking 3 meters, turning, returning to the chair, and sitting down. Each participant completed two trials, with the average time (in seconds) recorded for analysis(22). This average time also served as the single-task walking time for dual-task assessments. The TUG demonstrated excellent reliability (ICC >0.90) for participants with moderate neuropathy and good reliability (ICC 0.70-0.90) for those with severe neuropathy(23).
Single-Leg Stance Test Static balance was assessed using the Single-Leg Stance test. Participants stood on one leg with eyes open, maintaining the lifted foot without contact with the supporting limb or ground. The test continued for a maximum of 30 seconds or until termination due to: 1- contact between legs, 2- foot touching the floor, 3- hopping/jumping movements, or 4- use of external support - indicating balance impairment(24, 25). Research demonstrates that shorter single-leg stance times correlate with peripheral and cardiac autonomic nerve dysfunction as well as clinical neuropathy in type 2 diabetes patients, independent of age.(26).
Two-Point Discrimination (2PD) Test:
Sensory function was assessed using the Two-Point Discrimination (2PD) test. The 2PD threshold represents the minimum distance at which two simultaneous mechanical stimuli are perceived as distinct points. Testing was performed using a [brand/model name] two-point discriminator applied to the plantar surface of the foot. With eyes closed, participants verbally reported "one," "two," or "I can't tell" after each stimulus application (27).
Data Analysis All analyses adhered to the intention-to-treat principle, focusing exclusively on EMG RMS data. Between-group and longitudinal comparisons were conducted using repeated-measures ANOVA (α = 0.05) in SPSS version 26 (IBM Corp., Armonk, NY, USA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selected Multisensory Training (SMST) Group | Experimental | Behavioral: Selected Multisensory Training (SMST)Participants receive a 12-week supervised multisensory exercise program targeting balance, proprioception, and vestibular function. |
| Control Group | No intervention | –Participants engage in twice-weekly 40-minute unstructured group discussions without exercise intervention. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female sex
- Age 60 years or older
- Clinical diagnosis of diabetic peripheral neuropathy (DPN)
- Ability to stand unaided for at least 10 minutes
- Mini-Mental State Examination (MMSE) score ≥ 24
Key exclusion criteria (6 listed)
- Structural damage to lower extremities that affects balance or gait
- Severe neuropathy or other neurological disorders aside from DPN
- Cognitive impairment (MMSE score < 24)
- Any condition limiting participation in exercise (e.g., severe cardiovascular disease, recent fractures)
- Use of medications that significantly affect balance or neuromuscular function beyond typical diabetic treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selected Multisensory Training (SMST)A 12-week supervised exercise program involving two 40-minute sessions weekly. The program includes proprioceptive challenges on progressively firmer surfaces, vestibular activation with gait drills and head movements, and visual tracking tasks. Intensity progresses every three weeks by increasing surface instability, adding handheld weights, and reducing visual input (eyes open to eyes closed). The intervention aims to improve neuromuscular activation, balance, and sensory integration in older women with diabetic peripheral neuropathy. | Behavioural | Selected Multisensory Training (SMST) Group |
Primary outcome
Neuromuscular Activation (EMG RMS Amplitude)
Time frame: Baseline and after 12 weeks
Root Mean Square (RMS) amplitude of surface electromyography (sEMG) signals recorded from semitendinosus, rectus femoris, lateral gastrocnemius, and tibialis anterior muscles during postural control tasks in older women with diabetic peripheral neuropathy.
3 secondary outcomes
Balance Performance (Stork Balance Test)
Time frame: Baseline and after 12 weeks
Functional Mobility (Timed Up and Go Test)
Time frame: Baseline and after 12 weeks
sensory Function (Two-Point Discrimination Test)
Time frame: Minimum distance at which participants can distinguish two points on the plantar surface of the foot, measuring cutaneous sensory discrimination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- BackgroundMofateh R, Rahimzadeh S. The effects of multisensory exercises on balance control in people with diabetic peripheral neuropathy: a narrative review. Practical Diabetes. 2024;41(4):35-41. https://doi.org/10.1002/pdi.2522
- BackgroundKutty NAM, Majida NAL. Effects of multisensory training on balance and gait in persons with type 2 diabetes: a randomised controlled trial. Disability, CBR & Inclusive Development. 2013;24(2):79-91. https://doi.org/10.5463/dcid.v24i2.206
- Background: PubMed 32481239Ahmad I, Verma S, Noohu MM, Shareef MY, Hussain ME. Sensorimotor and gait training improves proprioception, nerve function, and muscular activation in patients with diabetic peripheral neuropathy: a randomized control trial. J Musculoskelet Neuronal Interact. 2020 Jun 1;20(2):234-248.
- BackgroundAsadi Ghaleni M, Sohrabi M, Taheri HR, Homam M. Effect of a multi-sensory training program on the balance of older women with diabetic peripheral neuropathy: a randomized controlled trial. The Scientific Journal of Rehabilitation Medicine. 2022;11(1):154-167. doi:10.32598/SJRM.11.1.10
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selected Multisensory Training (SMST) in people with Diabetic Peripheral Neuropathy (DPN), run by Monireh Asadi Ghaleni at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular Activation (EMG RMS Amplitude) (time frame: Baseline and after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07096570, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.