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IRCT20211022052835N5 IRCT 2022-03-24 Shifa Tameer-e-Millat University Comparison of Upper-Lower extremity Functional Training with Hand-Arm Bimanual Training to improve Performance in Hemiplegic Cerebral Palsy Comparison of Upper-Lower extremity Intensive Functional Training (U-LIFT) with Hand-Arm Bimanual Intensive Training-Including Lower Extremities (HABIT-ILE) to improve Global Functional Performance in Hemiplegic Cerebral Palsy. 2022-03-31 anticipated 30 Complete https://irct.ir/trial/61504 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Participants will be allocated into both groups by using Sealed Envelope method. Random numbers will be written on index cards and placed in thick and opaque sealed envelops. After taking a written consent from the child's guardian and verbal consent from the child, an envelope is opened and the patient is then offered the allocated treatment regimen, Blinding description: In this study participants, caregivers and outcome assessors will be blinded. So, it will be a double-blinded study. Prior to collecting data, children's guardian would be informed about details of treatment with its benefits and risks . Participants will be allocated into both groups by using Sealed Envelope method. Random numbers will be written on index cards and placed in thick and opaque sealed envelops. After taking a written consent from the child's guardian and verbal consent from the child, an envelope is opened and the patient is then offered the allocated treatment regimen. The group A or B belongs to which way of treatment is known to therapist but the patient/caregiver doesn't know about it. To make it a double blind, our primary outcomes 1MWT, PBS and AHA will be assessed by a blind assessor. N/A Spastic Hemiplegic Cerebral Palsy.. Intervention 1: Interventional Group A: Group-A will receive “Upper -Lower Extremity Intensive Functional Training (U-LIFT)". For upper-limb training following exercises will be used; 1-Strengthening Exercises: Progressive resistance training will be incorporated by using resistance bands, squeeze stress balls or salt dough, paper scrunching and using minimal weights (15 repetitions x 3 sets/day). 2-Balancing and Coordination Exercises: By putting blocks into a bucket , putting coins into a money box, piling up cup, using a spoon, pouring water into a cup ,drinking the water and moving drink cans/bottles (7 repetitions each x 2 sets /day). For lower-limb training following exercises will be used; 1-Strengthening Exercises: Sit to stand, step ups, vertical jumping, stair climbing will be done (15 repetitions each x 3 sets). 2-Muscles Specific Exercises for Gait: Bridges and heel raises. (5 repetitions each x 2 sets). 3-Balance Exercises: Tandem walking, one-leg standing and standing on balance board. (5 repetitions each x 3 sets) 4-Coordination Exercises: Ball kicking, jumping jacks or hopscotch (5-repetitions each x 3 sets). All exercises will be focused towards the affected side with appropriate warm up, cool down and rest periods among sets. Pre-Intervention (Baseline), Mid- Intervention (Midline) and Post-Intervention (Final) data will be taken. Intervention 2: Interventional Group B: Group-B will receive “Hand- Arm Bimanual Intensive Training Including Lower Extremities HABIT-ILE: For Upper Limb: Motor Learning Techniques in which instructions will be given to achieve goals like; Gross Motor tasks/activities -Fine Motor Tasks -Manipulative Tasks -Functional Tasks -Art or Crafts -Card Games -Video Games. All these activities of upper limb will be combined and challenged progressively with postural and locomotor activities of the lower limb, e.g., walking while holding a glass, drawing while sitting on an exercise ball. For Lower Limb, the contribution of the LE in the different tasks will also be advanced from: 1) Sitting activities e.g., initially on a chair or a mat, potentially with a back support, progressing towards unsupported sitting and sitting on an unstable support, such us on a roller or a ball. 2) Transitions from lower to higher postures using the UE for support. 3) Static gross motor activities e.g. from standing with UE support to playing in standing without UE support. 4) Dynamic activities e.g. crawling, walking, running or jumping. Pre-Intervention (Baseline), Mid- Intervention (Midline) and Post-Intervention (Final) data will be taken. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Fouzia Batool
Pitras Bukhari Road, H-8/4, Shifa Tameer-e-Millat University, Islamabad
Islamabad Pakistan 44000 +92 51 8441752 fouzia_dpt.ahs@stmu.edu.pk Shifa Tameer-e-Millat University scientific Fouzia Batool
Pitras Bukhari Road, H-8/4, Shifa Tameer-e-Millat University, Islamabad
Islamabad Pakistan 44000 +92 51 8441752 fouzia_dpt.ahs@stmu.edu.pk Shifa Tameer-e-Millat University Palau Pakistan Diagnosed hemiplegic Cerebral Palsy. Age 5-18 Gross Motor Function Classification System (GMFCS) II-IIII Manual Ability Classification System (MACS) II-IV Ability to follow any 2-step instruction 5 years 18 years Both Cognitive delay Modified Ashworth score greater than 3 Uncontrolled epilepsy Any recent orthopedic surgery Botulinum toxin injections within last 6 months Visual or auditory impairments Open wounds G80.2 Spastic hemiplegic cerebral palsy Rehabilitation Rehabilitation Interventional Group A: Group-A will receive “Upper -Lower Extremity Intensive Functional Training (U-LIFT)". For upper-limb training following exercises will be used; 1-Strengthening Exercises: Progressive resistance training will be incorporated by using resistance bands, squeeze stress balls or salt dough, paper scrunching and using minimal weights (15 repetitions x 3 sets/day). 2-Balancing and Coordination Exercises: By putting blocks into a bucket , putting coins into a money box, piling up cup, using a spoon, pouring water into a cup ,drinking the water and moving drink cans/bottles (7 repetitions each x 2 sets /day). For lower-limb training following exercises will be used; 1-Strengthening Exercises: Sit to stand, step ups, vertical jumping, stair climbing will be done (15 repetitions each x 3 sets). 2-Muscles Specific Exercises for Gait: Bridges and heel raises. (5 repetitions each x 2 sets). 3-Balance Exercises: Tandem walking, one-leg standing and standing on balance board. (5 repetitions each x 3 sets) 4-Coordination Exercises: Ball kicking, jumping jacks or hopscotch (5-repetitions each x 3 sets). All exercises will be focused towards the affected side with appropriate warm up, cool down and rest periods among sets. Pre-Intervention (Baseline), Mid- Intervention (Midline) and Post-Intervention (Final) data will be taken. Interventional Group B: Group-B will receive “Hand- Arm Bimanual Intensive Training Including Lower Extremities HABIT-ILE: For Upper Limb: Motor Learning Techniques in which instructions will be given to achieve goals like; Gross Motor tasks/activities -Fine Motor Tasks -Manipulative Tasks -Functional Tasks -Art or Crafts -Card Games -Video Games. All these activities of upper limb will be combined and challenged progressively with postural and locomotor activities of the lower limb, e.g., walking while holding a glass, drawing while sitting on an exercise ball. For Lower Limb, the contribution of the LE in the different tasks will also be advanced from: 1) Sitting activities e.g., initially on a chair or a mat, potentially with a back support, progressing towards unsupported sitting and sitting on an unstable support, such us on a roller or a ball. 2) Transitions from lower to higher postures using the UE for support. 3) Static gross motor activities e.g. from standing with UE support to playing in standing without UE support. 4) Dynamic activities e.g. crawling, walking, running or jumping. Pre-Intervention (Baseline), Mid- Intervention (Midline) and Post-Intervention (Final) data will be taken. Global Functional Performance, Balance and Functional Upper and Lower Extremity Abilities. Timepoint: Pre-Intervention at 0 week , Mid- Intervention after 2 weeks and Post-Intervention data after 4 weeks, will be taken. Method of measurement: • ACTIVLIM-CP, 1 Min Walk Test, Box and Block Test and Pediatric Balance Scale. Cerebral Palsy Quality of Life. Timepoint: Pre-intervention, after 2 weeks and post intervention after 4 weeks. Method of measurement: CP QOL (Cerebral Palsy Quality Of Life) - Child & Teen. Shifa Tameer-e-Millat University Approved 2022-01-15 Institutional Review Board & Ethics Committee (IRB & EC) Shifa International Hospital Ltd. (SIH), Sh Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad Islamabad Pakistan