NCT07096570

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2025

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

27 days

First QC Date

July 24, 2025

Last Update Submit

July 24, 2025

Conditions

Keywords

Diabetic Peripheral NeuropathyMultisensory TrainingElectromyography

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and after 12 weeks

Secondary Outcomes (3)

  • Balance Performance (Stork Balance Test)

    Baseline and after 12 weeks

  • Functional Mobility (Timed Up and Go Test)

    Baseline and after 12 weeks

  • sensory Function (Two-Point Discrimination Test)

    Minimum distance at which participants can distinguish two points on the plantar surface of the foot, measuring cutaneous sensory discrimination.

Study Arms (2)

Selected Multisensory Training (SMST) Group

EXPERIMENTAL

Participants receive a 12-week supervised multisensory exercise program targeting balance, proprioception, and vestibular function.

Behavioral: Selected Multisensory Training (SMST)

Control Group

NO INTERVENTION

Participants engage in twice-weekly 40-minute unstructured group discussions without exercise intervention.

Interventions

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.

Selected Multisensory Training (SMST) Group

Eligibility Criteria

Age60 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parsian Diabetes Clinic

Mashhad, 1993893973, Iran

Location

Related Publications (4)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 32481239BACKGROUND
  • Asadi 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

    BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Postdoctoral Researcher, Department of Motor Behavior, Faculty of Sport Sciences, Alzahra University

Study Record Dates

First Submitted

July 24, 2025

First Posted

July 31, 2025

Study Start

March 25, 2025

Primary Completion

April 21, 2025

Study Completion

June 22, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations