Effect of Hand Arm Bimanual Intensive Technique Including Lower Extremity (HABIT-IL) on Hemiplegic Cerebral Palsy
Primary Purpose
Hemiplegic Cerebral Palsy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL)
Hand Arm bimanual intensive Technique (HABIT)
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Hand arm bimanual intensive technique, Hemiplegic cerebral palsy, Functional status
Eligibility Criteria
Inclusion Criteria:
- Diagnosed cases of hemiplegic cerebral palsy
- GMFCS level 2,3,4
- Ashworth scale 0-2
Exclusion Criteria:
- History of recent orthopedic surgery
- History of seizures
- Visual impairment
Sites / Locations
- Mohi Ud Din Teaching Hospital (Mirpur AJK)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Hand arm Bimanual intensive Technique including Lower extremity (HABIT-IL)
Hand Arm bimanual intensive Technique (HABIT)
Arm Description
Hand arm Bimanual activities involving Lower extremity
Hand arm Bimanual activities without involvement of lower extremity
Outcomes
Primary Outcome Measures
six minute walk test
The object of this test is to walk as far as possible for 6 minutes. the patient will walk back and forth in this hallway. Six minutes is a long time to walk, so the patient will be exerting. he will probably get out of breath or become exhausted. patients are permitted to slow down, to stop, and to rest as necessary. he may lean against the wall while resting, but resume walking as soon as patients are able. the patient will be walking back and forth around the cones. the patient should pivot briskly around the cones and continue back the other way without hesitation Predictive equation for males: 6 Minute Walk Distance (m) = 867 - (5.71 age, yrs) + (1.03 height, cm) Predictive equation for females: 6 Minute Walk Distance(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI).
Gross motor function measure
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline.
SCORING KEY 0 = does not initiate
= initiates
= partially completes
= completes NT = Not tested
Box And Block
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity. During the performance of the BBT, the evaluator should be aware of whether the client's fingertips are crossing the partition. Blocks should be counted only when this condition is respected. Furthermore, if two blocks are transferred at once, only one block will be counted.
Assisting hand Assessment scale
AHA assesses the child's spontaneous and regular way of handling objects during play in natural settings, and is therefore a measure of usual everyday performance. AHA is appropriate to use for children with hemiplegic cerebral palsy (CP). 22 items consisting of observable actions, e.g. manipulates, varies grips, releases, and holds. The session is recorded and scored based on the 22 items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective).
The range of sum scores is 22-88 points.
Secondary Outcome Measures
Full Information
NCT ID
NCT05358028
First Posted
April 28, 2022
Last Updated
April 28, 2022
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05358028
Brief Title
Effect of Hand Arm Bimanual Intensive Technique Including Lower Extremity (HABIT-IL) on Hemiplegic Cerebral Palsy
Official Title
Comparison of Hand Arm Bimanual Intensive Technique With and Without Lower Extremity on Functional Status of Hemiplegic Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 15, 2022 (Anticipated)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
April 15, 2023 (Anticipated)
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 study is to determine the functional status of upper extremity using HABIT & HABIT-ILE. And to compare the effects of HABIT with and without lower extremity technique on functional status of hemiplegic cerebral palsy
Detailed Description
Hemiplegic cerebral palsy children have impairments in bimanual coordination above and beyond their unilateral impairments .Hand-arm bimanual intensive therapy tends to show a constructive impact on hand function in children with hemi paretic cerebral palsy.
Hand-Arm Bimanual Intensive Therapy (HABIT) designed for children with unilateral CP, which when combines bimanual upper extremity training with activities involving the trunk and lower extremities making it HABIT-ILE.
A bimanual training program that continuously focusses on postural control and lower limb functional activity is all covered in HABIT-ILE Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) involves the concepts of motor skill learning and intensive training to both the UE and LE.
However it is not known that whether combined upper and lower extremity training in an intensive protocol is more efficacious or not thus Rationale of this study would be to figure out that if an intensive protocol is devised involving upper and lower extremities both would it be more product full or not. This study would be significant in a way that we know cerebral palsy is a lifelong challenging condition for both children and their caregivers thus new and emerging treatments can be fruitful for progression.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Hand arm bimanual intensive technique, Hemiplegic cerebral palsy, Functional status
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hand arm Bimanual intensive Technique including Lower extremity (HABIT-IL)
Arm Type
Experimental
Arm Description
Hand arm Bimanual activities involving Lower extremity
Arm Title
Hand Arm bimanual intensive Technique (HABIT)
Arm Type
Active Comparator
Arm Description
Hand arm Bimanual activities without involvement of lower extremity
Intervention Type
Other
Intervention Name(s)
Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL)
Intervention Description
HABIT-ILE along with the conventional Bobath treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities.
Functional task as maintaining ADL:
i.Eating with spoon while standing ii. Combing hair while standing. iii. Counting cards while standing and putting them in box. Standing and walking I. standing with support of upper extremity II. walking with the help walkers III. walking on parallel bar playing activities: I. playing with cards while standings II. taking toys out of box and putting them in other box while standing III. grasping a fixed rod by hand and trying to maintain balance on physio stability ball
Intervention Type
Other
Intervention Name(s)
Hand Arm bimanual intensive Technique (HABIT)
Intervention Description
HAIBT along with the conventional Bobath treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities HAIBT along with the conventional Bobth treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities
Playing activities on table:
I. building towers with Lego blocks, II. Holding book by one hand and turning pages , III. Playing games with cards, IV. Drawing random impressions on paper, V. taking toys out of one box and placing them in other box one by one
Activities of daily living :
I. eating with spoon from bowel II. combing hair while sitting, III. opening of bottle cap for drinking water Age appropriate video games while sitting will be provided according to the ease of children
Primary Outcome Measure Information:
Title
six minute walk test
Description
The object of this test is to walk as far as possible for 6 minutes. the patient will walk back and forth in this hallway. Six minutes is a long time to walk, so the patient will be exerting. he will probably get out of breath or become exhausted. patients are permitted to slow down, to stop, and to rest as necessary. he may lean against the wall while resting, but resume walking as soon as patients are able. the patient will be walking back and forth around the cones. the patient should pivot briskly around the cones and continue back the other way without hesitation Predictive equation for males: 6 Minute Walk Distance (m) = 867 - (5.71 age, yrs) + (1.03 height, cm) Predictive equation for females: 6 Minute Walk Distance(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI).
Time Frame
6 weeks
Title
Gross motor function measure
Description
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline.
SCORING KEY 0 = does not initiate
= initiates
= partially completes
= completes NT = Not tested
Time Frame
6 week
Title
Box And Block
Description
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity. During the performance of the BBT, the evaluator should be aware of whether the client's fingertips are crossing the partition. Blocks should be counted only when this condition is respected. Furthermore, if two blocks are transferred at once, only one block will be counted.
Time Frame
6 weeks
Title
Assisting hand Assessment scale
Description
AHA assesses the child's spontaneous and regular way of handling objects during play in natural settings, and is therefore a measure of usual everyday performance. AHA is appropriate to use for children with hemiplegic cerebral palsy (CP). 22 items consisting of observable actions, e.g. manipulates, varies grips, releases, and holds. The session is recorded and scored based on the 22 items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective).
The range of sum scores is 22-88 points.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed cases of hemiplegic cerebral palsy
GMFCS level 2,3,4
Ashworth scale 0-2
Exclusion Criteria:
History of recent orthopedic surgery
History of seizures
Visual impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nadia Azhar, MS-NMPT
Phone
+923335281431
Email
nadia.azhar@riphah.edu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Azhar, MS-NMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mohi Ud Din Teaching Hospital (Mirpur AJK)
City
Mirpur
State/Province
Azad Kashmir
ZIP/Postal Code
13230
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayesha Mahnoor, MS-NMPT*
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Hand Arm Bimanual Intensive Technique Including Lower Extremity (HABIT-IL) on Hemiplegic Cerebral Palsy
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