Diabetic Peripheral NeuropathyFEToG-DPNNCT07616661
Feldenkrais vs. Task Oriented Gait Training on Diabetic Peripheral Neuropathy
A study testing Feldenkrais Exercises, Task Oriented Gait Training and baseline warm up and cool down Exercises in people with Diabetic Peripheral Neuropathy, run by University of Faisalabad at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 55 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Feldenkrais Exercises, Task Oriented Gait Training and baseline warm up and cool down Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2026to 28 May 2026
- 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 45 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Controlled blood glucose level
- Berg Balance scale = 21-40
- Willingness to participate and provide consent
Who cannot join
- Presence of ulcers at foot
- Lower leg amputation
- Charcot foot
- Retinopathy
- Hypertension
- Already receiving rehabilitation
Show all 10Show fewer
- History of trauma or fracture
- Any related orthopedic conditions
- CVS related conditions
- Autonomic neuropathy
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
The University of Faisalabad
Faisalābad, Punjab Province, 3800
About this study
Official title: Comparative Effects of Feldenkrais Exercises and Task Oriented Gait Training in Patients With 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.
Read the detailed description
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.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Feldenkrais Exercises, Task Oriented Gait Training, baseline warm up and cool down Exercises
- Keywords
- Feldenkrais, Task Oriented Gait Training, Balance, Proprioception, Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feldenkrais ExercisesOther
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 TrainingOther
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 ExercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| Feldenkrais Exercises | Experimental | Participants perform Feldenkrais exercises for 40 minutes per session, focusing on somatosensory re-education, axial movements, and balance. Receives: Other: Feldenkrais Exercises; Other: 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. Receives: Other: Task Oriented Gait Training; Other: baseline warm up and cool down Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 6, Week 12
Secondary outcomes (4)
Change in Cumulative Somatosensory Impairment Index (CSII)
Measures somatosensory postural control and functional awareness. Scale range and specific scoring will be calculated per the CSII manual.
Measured: Baseline, Week 6, Week 12
Change in Fear of Falling
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).
Measured: Baseline, Week 6, Week 12
Change in Quality of Life
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.
Measured: Baseline, Week 6, Week 12
Self-Awareness Learning Adherence
Measured by the return of a structured educational brochure checklist. Participants report if they performed prescribed home self-learning activities.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 Feb 2026
- Primary completion1 Apr 2026
- Study completion28 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Marium Zafar, University of Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616661
- Sponsor's protocol ID
- TUF/EIRB/ 221 /26
- Acronym
- FEToG-DPN
- Status last verified
- Sep 2026
- First submitted
- 23 May 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Feldenkrais Exercises and Task Oriented Gait Training in Patients With Diabetic Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT07616661
- Acronym / sponsor ID
- FEToG-DPN / TUF/EIRB/ 221 /26
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Feldenkrais, Task Oriented Gait Training, Balance, Proprioception, Neuropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of FaisalabadUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 28 May 2026 (actual)
- First posted
- 1 Jun 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feldenkrais Exercises | Experimental | Other: Feldenkrais Exercises, Other: baseline warm up and cool down ExercisesParticipants perform Feldenkrais exercises for 40 minutes per session, focusing on somatosensory re-education, axial movements, and balance. |
| Task Oriented Gait Training | Active comparator | Other: Task Oriented Gait Training, Other: baseline warm up and cool down ExercisesParticipants perform Task Oriented Gait Training for 45 minutes per session, focusing on functional tasks like walking on surfaces, changing directions, and obstacle negotiation. |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- Presence of ulcers at foot
- Lower leg amputation
- Charcot foot
- Retinopathy
- Hypertension
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 |
|---|---|---|
| Feldenkrais ExercisesThis 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. | Other | Feldenkrais Exercises |
| Task Oriented Gait TrainingThis 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. | Other | Task Oriented Gait Training |
| baseline warm up and cool down ExercisesWarm 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 | Other | Feldenkrais Exercises, Task Oriented Gait Training |
Primary outcome
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.
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.
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.
4 secondary outcomes
Change in Cumulative Somatosensory Impairment Index (CSII)
Time frame: Baseline, Week 6, Week 12
Change in Fear of Falling
Time frame: Baseline, Week 6, Week 12
Change in Quality of Life
Time frame: Baseline, Week 6, Week 12
Self-Awareness Learning Adherence
Time frame: Week 12
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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 Feldenkrais Exercises, Task Oriented Gait Training and baseline warm up and cool down Exercises in people with Diabetic Peripheral Neuropathy, run by University of Faisalabad at 1 site in Pakistan.
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 9 inclusion and 10 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 10 Sep 2026. 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 Pakistan. 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?
Change in Berg Balance Scale Score (time frame: Baseline, Week 6, Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.