NCT07616661

Brief Summary

Diabetic Peripheral Neuropathy (DPN) causes balance problems, falls, and sensory loss in the feet. This study compares two non-drug exercise programs to see which works better. The first program is Feldenkrais exercises, which focus on movement awareness and retraining the brain. The second program is Task Oriented Gait Training, which practices specific walking tasks. Researchers will measure balance, joint position sense, touch sensation, fear of falling, and quality of life. Forty participants will be split into two groups. The study will last 12 weeks.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2026

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
Last Updated

June 1, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 23, 2026

Last Update Submit

May 23, 2026

Conditions

Keywords

FeldenkraisTask Oriented Gait TrainingBalanceProprioceptionNeuropathy

Outcome Measures

Primary Outcomes (3)

  • Change in Berg Balance Scale Score

    The Berg Balance Scale (BBS) measures static and dynamic balance. It contains 14 items scored from 0 to 4. Total score ranges from 0 to 56. Higher scores indicate better balance.

    Baseline, Week 6, Week 12

  • Change in Ankle Joint Proprioception

    Measured using the Joint Position Sense Test (JPST) with a goniometer. The participant actively reproduces a target joint angle. The difference in degrees between the target and the reproduction is recorded. Smaller differences indicate better proprioception.

    Baseline, Week 6, Week 12

  • Change in Tactile Sensation

    Measured using the Semmes-Weinstein Monofilament (10g). The filament is applied to 10 sites on the plantar surface of the foot. The number of correctly detected applications out of 10 is recorded. Higher scores indicate better sensation.

    Baseline, Week 6, Week 12

Secondary Outcomes (4)

  • Change in Cumulative Somatosensory Impairment Index (CSII)

    Baseline, Week 6, Week 12

  • Change in Fear of Falling

    Baseline, Week 6, Week 12

  • Change in Quality of Life

    Baseline, Week 6, Week 12

  • Self-Awareness Learning Adherence

    Week 12

Study Arms (2)

Feldenkrais Exercises

EXPERIMENTAL

Participants perform Feldenkrais exercises for 40 minutes per session, focusing on somatosensory re-education, axial movements, and balance.

Other: Feldenkrais ExercisesOther: baseline warm up and cool down Exercises

Task Oriented Gait Training

ACTIVE COMPARATOR

Participants perform Task Oriented Gait Training for 45 minutes per session, focusing on functional tasks like walking on surfaces, changing directions, and obstacle negotiation.

Other: Task Oriented Gait TrainingOther: baseline warm up and cool down Exercises

Interventions

Warm up exercises: Warm up exercises before the start of training exercises for about ten minutes. These include: • Leg swings (forward and backward) • Side to side leg swings • Leg kicks 20 reps/side • Standing on tip toes • Mild stretching Cool down exercises: Cool Down exercises after the end of training exercises for about ten minutes to induce relaxation. These include: • Deep breathing exercise • Abdominal breathing exercise • Leg swings • Standing on tip toes • Mild stretching

Feldenkrais ExercisesTask Oriented Gait Training

This intervention includes 16 specific movement lessons (e.g., turning improvement, weight transference, sensing the feet, walking in tandem). The protocol is derived from Mazuelas et al. 2024. Sessions are 40 minutes, twice a week for 12 weeks, guided by a physiotherapist.

Feldenkrais Exercises

This intervention includes functional tasks such as walking with reduced base of support, obstacle crossing, and ramp walking. The protocol is derived from Salsabili et al. 2015. Sessions are 45 minutes, twice a week for 12 weeks.

Task Oriented Gait Training

Eligibility Criteria

Age45 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age ranges from 45-55 years
  • Diagnosed type 1 and type 2 diabetes
  • Suffered from a fall in last 6 months
  • MNSI Questionnaire scored \> 2/13
  • MNSI physical assessment scored \> 4/10
  • BMI = 18.5 - 29.9
  • Controlled blood glucose level
  • Berg Balance scale = 21-40
  • Willingness to participate and provide consent

You may not qualify if:

  • Presence of ulcers at foot
  • Lower leg amputation
  • Charcot foot
  • Retinopathy
  • Hypertension
  • Already receiving rehabilitation
  • History of trauma or fracture
  • Any related orthopedic conditions
  • CVS related conditions
  • Autonomic neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

Location

MeSH Terms

Interventions

Cool-Down Exercise

Intervention Hierarchy (Ancestors)

Post-Exercise Recovery TechniquesPhysical Therapy ModalitiesTherapeuticsRehabilitationExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Rehabilitation Sciences

Study Record Dates

First Submitted

May 23, 2026

First Posted

June 1, 2026

Study Start

February 1, 2026

Primary Completion

April 1, 2026

Study Completion

May 28, 2026

Last Updated

June 1, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations