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IRCT20230615058491N1 IRCT 2023-11-12 Rehman Medical Institute RMI Effects of Theraband-assisted training on balance and gait outcomes in stroke patients The effects of Theraband-assisted treadmill training on balance and gait outcomes in stroke patients: A randomised controlled trial 2023-09-18 anticipated 50 Complete https://irct.ir/trial/72444 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In our trial, randomization will be conducted using a sealed envolpe method. The unit of randomization is the individual participant. For each participant, a unique identifier will be assigned, and these identifiers will be placed in separate, opaque, and sealed envelopes. The envelopes will be thoroughly mixed before a neutral third party, who is not involved in the trial, draws an envelope for each participant. The treatment assignment corresponding to the label inside the drawn envelope will determine whether the participant receives Theraband-assisted treadmill training or standard treadmill training. This method ensures the transparency and fairness of the allocation process, eliminating any potential for selection bias. Allocation concealment will be maintained throughout the trial, as the envelopes will be securely stored and opened only at the time of participant allocation, Blinding description: One physical therapist will provide the treatment session, another physical therapist will assess the pre and post Tx outcomes of the patients from both groups, outcomes assessor will be blinded in this study. N/A Stroke. Intervention 1: Intervention group: • A total of 50 minutes session will be given which will include Treadmill training with theraband for 30 minutes in a harness support and conventional therapy (general stretching & strengthening exercises) for 20 minutes, 5 days a week for a total of 4 weeks.• 30 minutes treadmill training will be given in three sets each of 10 minutes (8 minutes training with 2 minutes rest in between).• Participants will walk on treadmill at a normal pace. Speed for the first 2 weeks will be 1m/s and of the last 2 weeks will be 1.5m/s. • Two theraband will be used, green color theraband will be used to assist dorsiflexion, while the black theraband will be tied to an abdominal belt crossing in front of the ankle, back of the knee and front of the hip joint. Intervention 2: Control group: • A total of 50 minutes session will be given which will include Treadmill training for 30 minutes in a harness support and conventional therapy (general stretching & strengthening exercises) for 20 minutes, 5 days a week for a total of 4 weeks.• 30 minutes treadmill training will be given in three sets each of 10 minutes (8 minutes training with 2 minutes rest in between).• Participants will walk on treadmill at a normal pace. Speed for the first 2 weeks will be 1m/s and of the last 2 weeks will be 1.5m/s. Yes - There is a plan to make this available What will be shared: Primary outcomes data When: Data will be availabe in January 2024 for two years To whom: All the students, teachers and resreach scholars Conditions: The person will have to email the principal investigator for data Where to obtain: From Prinicapal investigator How to obtain: Through mail communication with author Comments:
public Maaham Ali
5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa
Peshwar Pakistan 25000 +92 336 8830999 maahamali99@gmail.com Khyber medical university scientific Maaham Ali
5-B/2 Shaukat Khanum Rd, Phase 5 Hayatabad, Peshawar, Khyber Pakhtunkhwa
Peshawar Pakistan 25000 +92 336 8830999 maahamali99@gmail.com Khyber medical university Pakistan Stroke onset greater than 6 months. Age between 30-65yrs. Ability to follow one step command, MMSE scores ≥24. Ability to walk independently or with assistive device. Participants who are interested and able to take part in a supervised rehabilitation program for at least 4 weeks. 30 years 65 years Both More than one hemisphere involved. Recurrent strokes greater than two. Participants with any diagnosed cardiovascular illness or diabetic neuropathy. Participants with any diagnosed neurological or musculoskeletal problems, other than stroke, that impact their gait or balance. Participants who currently have or have previously had any diagnosed vestibular problems. Having any diagnosed significant lower limb abnormalities (e.g. clubfoot, polio, foot drop, fractures). G46.4 Cerebellar stroke syndrome Treatment - Other Treatment - Other Intervention group: • A total of 50 minutes session will be given which will include Treadmill training with theraband for 30 minutes in a harness support and conventional therapy (general stretching & strengthening exercises) for 20 minutes, 5 days a week for a total of 4 weeks.• 30 minutes treadmill training will be given in three sets each of 10 minutes (8 minutes training with 2 minutes rest in between).• Participants will walk on treadmill at a normal pace. Speed for the first 2 weeks will be 1m/s and of the last 2 weeks will be 1.5m/s. • Two theraband will be used, green color theraband will be used to assist dorsiflexion, while the black theraband will be tied to an abdominal belt crossing in front of the ankle, back of the knee and front of the hip joint. Control group: • A total of 50 minutes session will be given which will include Treadmill training for 30 minutes in a harness support and conventional therapy (general stretching & strengthening exercises) for 20 minutes, 5 days a week for a total of 4 weeks.• 30 minutes treadmill training will be given in three sets each of 10 minutes (8 minutes training with 2 minutes rest in between).• Participants will walk on treadmill at a normal pace. Speed for the first 2 weeks will be 1m/s and of the last 2 weeks will be 1.5m/s. GAIT. Timepoint: Before intervention as a baseline and then at the end of intervention after 4 weeks. Method of measurement: 10 meter walk test will be used to assess the GAIT outcome of patient. A stopwatch and a 10 m pathway will be required for the test. A score of <0.4m/s shows household ambulation, 0.4-0.8m/s shows limited community ambulation and >0.8m/s shows community ambulation. Balance. Timepoint: Before intervention as a baseline and then at the end of intervention after 4 weeks. Method of measurement: Functional reach test will be used to assess the balance of the participants. It will need measuring tape on the wall and patient will lean forward and score will be noted. A score of greater than 25 will be considered low risk, 15-25 moderate risk and less than 15 high risk of fall. Rehman Medical Institute RMI Approved 2023-09-04 KMU AS&RB Hayatabad phase 5 Peshawar Khyber pakhtunkhwa Pakistan