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.
-To determine role of both treatment techniques to improve Global Functional Performance.
-To determine the comparative balance improvement among the participants of both groups.
-To determine the efficacy of the treatment techniques to improve functions of both upper and lower limb.
Secondary Objective:
-To assess the “Quality of Life” among participants of both groups.
Design
Randomized Control Trial (RCT) Double blind study. Study groups: U-LIFT and HABIT-ILE . Phase: N.A Sample size:30, Randomization: Simple random sampling technique is used by sealed envelop method. The study is double blinded as participants/caregivers and outcome assessors are blinded. Study center: Multi study centers.
Settings and conduct
The Children Complex Multan and CMH, Multan. All caregivers will be informed about the study and will sign written informed consent before interventions. Simple random sampling technique will be used by sealed envelop method. Study is double blinded as participants/caregivers and outcome assessors are blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
•Diagnosed hemiplegic Cerebral Palsy
•Age 5-18
•Gross Motor Function Classification System score II-III
• Manual Ability Classification System score II-IV
•Ability to follow any 2-step instruction.
Exclusion Criteria:
•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
Intervention groups
There are 2 interventional groups; Group A and B. Group A :Upper-Lower Extremity Functional Training (U-LIFT) group; Group B: Hand-Arm Bimanual Intensive Training- Including Lower Extremities (HABIT-ILE) group.
Main outcome variables
• ACTIVLIM-CP (Activity Limitations for Patients with Cerebral Palsy)
• 1-Min Walk test
• Pediatric Balance Scale
• The Box and Block Test .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211022052835N5
Registration date:2022-03-24, 1401/01/04
Registration timing:prospective
Last update:2022-03-24, 1401/01/04
Update count:0
Registration date
2022-03-24, 1401/01/04
Registrant information
Name
Fouzia Batool
Name of organization / entity
Shifa Tameer-e-Millat University
Country
Pakistan
Phone
+92 51 8441752
Email address
fouzia_dpt.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-31, 1401/01/11
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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.
Public title
Comparison of Upper-Lower extremity Functional Training with Hand-Arm Bimanual Training to improve Performance in Hemiplegic Cerebral Palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 5 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board & Ethics Committee (IRB & EC) Shifa International Hospital Ltd. (SIH), Sh
Street address
Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad
City
Islamabad
Postal code
44790
Approval date
2022-01-15, 1400/10/25
Ethics committee reference number
IRB#349-21
Health conditions studied
1
Description of health condition studied
Spastic Hemiplegic Cerebral Palsy.
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
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.
Secondary outcomes
1
Description
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.
Intervention groups
1
Description
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.
Category
Rehabilitation
2
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Combined Military Hospital
Full name of responsible person
Shifa Saleem
Street address
Ghaus ul Azam Road، near Naseem Hayat Rd، Pia Colony, Multan, Punjab
City
Multan
Postal code
60000
Phone
Email
shifa59a@gmail.com
2
Recruitment center
Name of recruitment center
Children's Hospital & The Institute of Child Health Multan.
Full name of responsible person
Shifa Saleem
Street address
Sher Shah Road, Nawa Shehar Mohalla Qadirabad, Multan, Punjab