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IRCT20200326046864N1 IRCT 2020-04-19 Tehran University of Medical Sciences EMG-biofeedback in muscular dystrophy The comparison of effectiveness of strengthening exercises with and without EMG-biofeedback on function in patients with muscular dystrophy 2020-06-21 anticipated 40 Complete https://irct.ir/trial/46754 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: An independent researcher makes random allocation cards using computer-generated allocation table with stratification on sex and random block sizes of two and four within each stratum. He keeps the original random allocation sequences in an inaccessible third place and works with a copy. An unblinded clinical coordinator, who is not involved in testing or recruitment, will randomize subjects, Blinding description: Blinded study personnel will consist of the principal investigator, study coordinators, outcomes assessors, and the biostatistician. Unblinded study personnel will consist of the clinical coordinator and occupational therapists delivering the intervention. Participants will only be aware that they are participating in one of two potential rehabilitation programs and will be instructed to not discuss any details of their program with any blinded personnel. N/A Muscular dystrophy. Intervention 1: Intervention group: strengthening exercises using EMG-biofeedback. EMG biofeedback is a method of retraining muscle by creating new feedback systems as a result of the conversion of myoelectrical signals in the muscle into visual and auditory signals. The program for intervention group utilizes the Loadsol® insoles (Novel.de, Munich, Germany) as real-time visual biofeedback during activity performance.The participants will do biofeedback assisted exercises for 6 weeks and 2 times a week with at least one day interval. Each session will take about 30-40 minutes.Exercises provided on the flexor, abductor and adductor muscles of the hip and knee flexors and extensors. The participants will be assessed for retention of motor learning from the previous session on their current activities to determine if they are ready for intervention progression. The frequency of biofeedback will be faded to 50% using an intermittent biofeedback schedule along with random practice of the activities to promote retention of the improved movement pattern. The INTERVENTION group home exercise program will be the same as the CONTROL group home exercise program focusing on 10 strengthening and balance improving exercises. Intervention 2: Control group: strengthening exercises with occupational therapist supervision, Participants enrolled in the CONTROL program will focus on the same exercise protocol as the intervention program, though the treating occupational therapist will not provide any instructed feedback on movement patterns during their treatment beyond minimal cues for safety. Progression within activities in the CONTROL group will be based upon the participant's tolerance and safety in performing the activity. The CONTROL home exercise program will be the same as the intervention group but without use of biofeedback. Yes - There is a plan to make this available What will be shared: The findings of this study will be published as soon as possible. When: 2022 To whom: results will be available for journals readers data will be available for reasonable requests for example systematic reviews Conditions: systematic review and meta analysis Where to obtain: Shariati Hospital, Tehran, Rehabilitation Department How to obtain: Through email: nasi_lam@yahoo.com Comments:
public Nastaran Maghbouli
No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1418815516 +98 21 8490 2110 nasi_lam@yahoo.com Tehran University of Medical Sciences scientific Nastaran Maghbouli
No. 25, Jalal Al-Ahmad Highway, North Kargar Street, Tehran
Tehran Iran (Islamic Republic of) 1418815516 +98 21 8490 2110 nasi_lam@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Muscular dystrophy with proximal muscles involvement Approved muscular dystrophy diagnosis by neurologist Ability to walk 10 meters without help To be volunteer for intervention 18 years no limit Both Using drugs affecting muscular strength Acute myositis Orthopedic problems limiting patient movements Other neurologic or systemic disease involving muscles Skin lesion or infection at the site of electrode placements History of symptomatic cardiomyopathy G71.00 G71.00 - Muscular dystrophy, unspecified Rehabilitation Rehabilitation Intervention group: strengthening exercises using EMG-biofeedback. EMG biofeedback is a method of retraining muscle by creating new feedback systems as a result of the conversion of myoelectrical signals in the muscle into visual and auditory signals. The program for intervention group utilizes the Loadsol® insoles (Novel.de, Munich, Germany) as real-time visual biofeedback during activity performance.The participants will do biofeedback assisted exercises for 6 weeks and 2 times a week with at least one day interval. Each session will take about 30-40 minutes.Exercises provided on the flexor, abductor and adductor muscles of the hip and knee flexors and extensors. The participants will be assessed for retention of motor learning from the previous session on their current activities to determine if they are ready for intervention progression. The frequency of biofeedback will be faded to 50% using an intermittent biofeedback schedule along with random practice of the activities to promote retention of the improved movement pattern. The INTERVENTION group home exercise program will be the same as the CONTROL group home exercise program focusing on 10 strengthening and balance improving exercises. Control group: strengthening exercises with occupational therapist supervision, Participants enrolled in the CONTROL program will focus on the same exercise protocol as the intervention program, though the treating occupational therapist will not provide any instructed feedback on movement patterns during their treatment beyond minimal cues for safety. Progression within activities in the CONTROL group will be based upon the participant's tolerance and safety in performing the activity. The CONTROL home exercise program will be the same as the intervention group but without use of biofeedback. Muscle strength. Timepoint: before intervention, after 6 weeks intervention, 3 months post intervention. Method of measurement: dynamometer. Motor Function. Timepoint: before, 6 weeks and 3 months post intervention. Method of measurement: The Motor Function Measure-32 scale. Fatigue severity. Timepoint: before, 6 weeks and 3 months post intervention. Method of measurement: Fatigue severity scale. Balance. Timepoint: before, 6 weeks and 3 months post intervention. Method of measurement: Berg Balance Scale. Quality of life. Timepoint: before, 6 weeks and 3 months post intervention. Method of measurement: SF-36 for quality of life evaluation. Tehran University of Medical Sciences Approved 2019-04-27 Ethics Committee of School of Medicine- Tehran University of Medical Sciences North Kargar Tehran Tehran Iran (Islamic Republic of)