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NCT Number: NCT07616661

Feldenkrais vs. Task Oriented Gait Training on Diabetic Peripheral Neuropathy

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy

Age range

45 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Faisalabad

Faisalābad, Punjab Province, 3800, Pakistan

About this study

This study is a single-blinded, randomized clinical trial. Forty participants with Diabetic Peripheral Neuropathy (DPN) will be recruited from Shahid Heera's Health Clinic and Madinah Teaching Hospital in Faisalabad. Participants will be screened using the Michigan Neuropathy Screening Instrument (MNSI). Inclusion criteria include participants aged 45-55 years with type 1 or type 2 diabetes, a history of at least one fall in the past six months, a body mass index between 18.5 and 29.9, controlled blood glucose levels, and a Berg Balance Scale score between 21 and 40. Participants will be excluded if they have foot ulcers, lower leg amputation, Charcot foot, retinopathy, hypertension, or are already receiving rehabilitation.

Eligible participants will be randomly allocated into two groups of twenty using a computer-generated method. Group A will receive Feldenkrais exercises. Group B will receive Task Oriented Gait Training. Both groups will attend two sessions per week for twelve weeks. Each session lasts sixty minutes, consisting of a ten-minute warm-up, a forty-to-forty-five-minute main exercise session, and a ten-minute cool-down. Outcome measures will be recorded at baseline, the sixth week, and the twelfth week. The primary outcome measures are static and dynamic balance (Berg Balance Scale), ankle joint proprioception (joint position sense test), and tactile sensation (monofilament test). The secondary outcome measures are somatosensory postural control (Cumulative Somatosensory Impairment Index), fear of falling (Fall Efficacy Scale), self-awareness learning (educational brochure), and quality of life (SF-36 Questionnaire). SPSS version 20 will be used for statistical analysis.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Feldenkrais exercises

Other

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.

Task Oriented Gait Training

Other

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.

baseline warm up and cool down Exercises

Other

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

Primary outcomes

  1. Change in Berg Balance Scale Score

    Time frame: Baseline, Week 6, Week 12

    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.

  2. Change in Ankle Joint Proprioception

    Time frame: Baseline, Week 6, Week 12

    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.

  3. Change in Tactile Sensation

    Time frame: Baseline, Week 6, Week 12

    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.

Secondary outcomes

  1. Change in Cumulative Somatosensory Impairment Index (CSII)

    Time frame: Baseline, Week 6, Week 12

    Measures somatosensory postural control and functional awareness. Scale range and specific scoring will be calculated per the CSII manual.

  2. Change in Fear of Falling

    Time frame: Baseline, Week 6, Week 12

    Measured using the Fall Efficacy Scale (FES). Participants rate confidence in performing 10 activities without falling. Scores range from 10 (high confidence) to 100 (low confidence).

  3. Change in Quality of Life

    Time frame: Baseline, Week 6, Week 12

    Measured using the SF-36 Questionnaire. This tool assesses physical and mental health across 8 domains. Scores are transformed into a scale from 0 to 100. Higher scores indicate better quality of life.

  4. Self-Awareness Learning Adherence

    Time frame: Week 12

    Measured by the return of a structured educational brochure checklist. Participants report if they performed prescribed home self-learning activities.

Sponsors and collaborators

Lead sponsor

University of Faisalabad

Other

Registry information

Official study title

Comparative Effects of Feldenkrais Exercises and Task Oriented Gait Training in Patients With Diabetic Peripheral Neuropathy

Acronym: FEToG-DPN

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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