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CIMT and BIMT Affect Functional Outcome in CP

Primary Purpose

Cerebral Palsy, Congenital

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Constraint induced movement therapy
Bimanual activities
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Congenital focused on measuring Cerebral Palsy, Neurorehabilitation, Spasticity

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with age group of 5-12 years. Patients with hemiplegic cerebral palsy of both genders. Patients who have active wrist extension, active PIP -MCP joint extension and active thumb extension.

Patients who have mild spasticity on spasticity rating scale of QUEST test Patients who fall on level II on MAC System are included Patients who has cognitive dysfunction ( screening by WISC Wechsler Intelligence test for children) all have score above 80.

Exclusion Criteria:

  • Patients who can develop any sort of behavior problems Patients who does not co-operate with therapist in CIMT procedure Any structural deformity. Any surgical intervention that requires patient to be immobile.

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Constraint induced movement therapy group

Bimanual activities group; BIM training

Arm Description

Constrained on more affected side for three hours.

Set of bimanual activities performed.

Outcomes

Primary Outcome Measures

Quality of upper extremity skills test
Quality of upper extremity skills test or QOL quality of life. This scoring includes dissociated movements, grasps, weight bearing and protected extension. This scoring helps the therapist to determine which functional limitations needs to be addressed for better flexion extension abduction and other related movements to improve quality of life . It includes 36 items to be tested and thirty to forty minutes to apply and assess the test.
JEBSEN Hand Function Test
The JEBSEN Hand Function Test was designed to provide a comprehensive, objective test of hand function for actions of daily living. It has 7 items and takes approximately 15-45 minutes to administer. 7 items include: writing, turning over 3-by-5 inch cards, picking up small common objects, stacking checkers, simulated feeding, picking up large light objects and picking up large heavy objects. The results are calculated by timing the time taken to complete each task. The tests are always presented in the same order and are performed with the non-dominant hand first

Secondary Outcome Measures

Manual ability classification
The Manual Ability Classification System (MACS) describes how children with (CP) use their hands to carry objects in daily routine. MAC describes 5 levels. These levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. The MACS also describe differences between adjacent levels to make it easier to determine which level best corresponds with the child's capability to handle objects. The objects are relevant and age-appropriate for the children, used when they perform tasks such as eating, dressing, playing, drawing or writing. Etc.

Full Information

First Posted
December 23, 2019
Last Updated
December 23, 2019
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04211623
Brief Title
CIMT and BIMT Affect Functional Outcome in CP
Official Title
Comparison of Constrained Induced Movement Therapy and Bimanual Intensive Movement Therapy on Functional Outcome of Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this randomized controlled trial is to determine the effects of constraint induced movement therapy CIMT and BIM bimanual activities on functional outcome in hemiplegic CP. Two randomized groups of patients with CP are treated with constrained arm for three hours on affected side and bimanual activities on BIM group respectively. Both, male and female patients meeting the inclusion criteria will be included. Patients having concurrent malignancy, infection, trauma or any bony deformity will be excluded.
Detailed Description
It is a Randomized control trial. Cerebral palsy children of age groups of 5 yrs to 12 years were included in the study with total sample size of thirty eight (38) with confidence interval of 95%. Simple random sampling was done by lottery method and data was collected from ALFARABI special school of education Islamabad. Two groups were formed and named as group A; CIMT with nineteen participants and group B, BIM bimanual training with nineteen participants respectively. The RCT compared the functional outcome of 3 hours constraining for 3 times a week for 6 weeks duration for CIMT group and five bimanual activities performed for three hours a day for bimanual group B and were assessed on the pretest and post test score evaluation of QUEST and JTHF test. All the participants were hemiplegic cp from both gender, fall on MAC system level II. Treatment for three hours was done on alternate days for 3 days a week. Five bimanual activites of holding a tray, cutting a fruit with knife, buttoning, cutting paper with scissor, and carry heavy objects with both hands are applied. Whereas the activities performed in CIMT are brushing teeth, holding spoon, fork combing hair and writing. Forty five children were screened before the evaluation and as a result 38 were enrolled in both groups having 19 in each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Congenital
Keywords
Cerebral Palsy, Neurorehabilitation, Spasticity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Constraint induced movement therapy group
Arm Type
Active Comparator
Arm Description
Constrained on more affected side for three hours.
Arm Title
Bimanual activities group; BIM training
Arm Type
Active Comparator
Arm Description
Set of bimanual activities performed.
Intervention Type
Other
Intervention Name(s)
Constraint induced movement therapy
Intervention Description
Constrained on more affected side for three hours. To minimize the learned non use in hemiplegic CIMT is applied and criteria of applying CIMT is; 10 degrees active wrist extension on the affected hand, 10 degrees active thumb abduction, 10 º active extension of any two digits on the side or hand which is limited due to damage. In order to gain the maximum good results from CIMT technique following points should also be considered attentively. Affected arm should move to 45 degrees shoulder flexion and abduction, and 90 degrees of elbow flexion and extension. Constrained with cotton sling. 3 to 5 upper limb functional activities like using fork or a spoon, combing hair brushing teeth writing dressing all activities are performed for 10 t0 15 minutes in period of three hours on alternate days in a week
Intervention Type
Other
Intervention Name(s)
Bimanual activities
Intervention Description
Bimanual activities of both hands are performed like Set of bimanual activities is used to assess the bimanual hand function. Five bimanual activities are performed such as carrying a tray, cutting a fruit with a knife, holding and cutting the paper with scissor, buttoning and Carrying heavy objects with both hands. Every activity was performed for 10 t0 15 minutes on alternate days for a period of 6 weeks session.
Primary Outcome Measure Information:
Title
Quality of upper extremity skills test
Description
Quality of upper extremity skills test or QOL quality of life. This scoring includes dissociated movements, grasps, weight bearing and protected extension. This scoring helps the therapist to determine which functional limitations needs to be addressed for better flexion extension abduction and other related movements to improve quality of life . It includes 36 items to be tested and thirty to forty minutes to apply and assess the test.
Time Frame
6 weeks
Title
JEBSEN Hand Function Test
Description
The JEBSEN Hand Function Test was designed to provide a comprehensive, objective test of hand function for actions of daily living. It has 7 items and takes approximately 15-45 minutes to administer. 7 items include: writing, turning over 3-by-5 inch cards, picking up small common objects, stacking checkers, simulated feeding, picking up large light objects and picking up large heavy objects. The results are calculated by timing the time taken to complete each task. The tests are always presented in the same order and are performed with the non-dominant hand first
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Manual ability classification
Description
The Manual Ability Classification System (MACS) describes how children with (CP) use their hands to carry objects in daily routine. MAC describes 5 levels. These levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. The MACS also describe differences between adjacent levels to make it easier to determine which level best corresponds with the child's capability to handle objects. The objects are relevant and age-appropriate for the children, used when they perform tasks such as eating, dressing, playing, drawing or writing. Etc.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with age group of 5-12 years. Patients with hemiplegic cerebral palsy of both genders. Patients who have active wrist extension, active PIP -MCP joint extension and active thumb extension. Patients who have mild spasticity on spasticity rating scale of QUEST test Patients who fall on level II on MAC System are included Patients who has cognitive dysfunction ( screening by WISC Wechsler Intelligence test for children) all have score above 80. Exclusion Criteria: Patients who can develop any sort of behavior problems Patients who does not co-operate with therapist in CIMT procedure Any structural deformity. Any surgical intervention that requires patient to be immobile.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mir Arif Hussain, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Islamabad
ZIP/Postal Code
44000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17044964
Citation
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Results Reference
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16097492
Citation
Charles J, Gordon AM. A critical review of constraint-induced movement therapy and forced use in children with hemiplegia. Neural Plast. 2005;12(2-3):245-61; discussion 263-72. doi: 10.1155/NP.2005.245.
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PubMed Identifier
19451190
Citation
Sakzewski L, Ziviani J, Boyd R. Systematic review and meta-analysis of therapeutic management of upper-limb dysfunction in children with congenital hemiplegia. Pediatrics. 2009 Jun;123(6):e1111-22. doi: 10.1542/peds.2008-3335. Epub 2009 May 18.
Results Reference
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PubMed Identifier
17979861
Citation
Gordon AM, Schneider JA, Chinnan A, Charles JR. Efficacy of a hand-arm bimanual intensive therapy (HABIT) in children with hemiplegic cerebral palsy: a randomized control trial. Dev Med Child Neurol. 2007 Nov;49(11):830-8. doi: 10.1111/j.1469-8749.2007.00830.x.
Results Reference
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PubMed Identifier
17944294
Citation
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Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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CIMT and BIMT Affect Functional Outcome in CP

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