Feldenkrais vs. Task Oriented Gait Training on Diabetic Peripheral Neuropathy (FEToG-DPN)
Comparative Effects of Feldenkrais Exercises and Task Oriented Gait Training in Patients With Diabetic Peripheral Neuropathy
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Punjab Province
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Faisalābad, Punjab Province, Pakistan, 3800
- The University of Faisalabad
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Feldenkrais Exercises
Participants perform Feldenkrais exercises for 40 minutes per session, focusing on somatosensory re-education, axial movements, and balance.
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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.
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
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Aktywny komparator: Task Oriented Gait Training
Participants perform Task Oriented Gait Training for 45 minutes per session, focusing on functional tasks like walking on surfaces, changing directions, and obstacle negotiation.
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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
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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Berg Balance Scale Score
Ramy czasowe: Baseline, Week 6, Week 12
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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.
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Baseline, Week 6, Week 12
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Change in Ankle Joint Proprioception
Ramy czasowe: Baseline, Week 6, Week 12
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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.
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Baseline, Week 6, Week 12
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Change in Tactile Sensation
Ramy czasowe: Baseline, Week 6, Week 12
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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.
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Baseline, Week 6, Week 12
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Cumulative Somatosensory Impairment Index (CSII)
Ramy czasowe: Baseline, Week 6, Week 12
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Measures somatosensory postural control and functional awareness.
Scale range and specific scoring will be calculated per the CSII manual.
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Baseline, Week 6, Week 12
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Change in Fear of Falling
Ramy czasowe: Baseline, Week 6, Week 12
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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).
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Baseline, Week 6, Week 12
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Change in Quality of Life
Ramy czasowe: Baseline, Week 6, Week 12
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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.
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Baseline, Week 6, Week 12
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Self-Awareness Learning Adherence
Ramy czasowe: Week 12
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Measured by the return of a structured educational brochure checklist.
Participants report if they performed prescribed home self-learning activities.
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Week 12
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- TUF/EIRB/ 221 /26
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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