Effect of Hand Arm Bimanual Intensive Technique Including Lower Extremity (HABIT-IL) on Hemiplegic Cerebral Palsy

Comparison of Hand Arm Bimanual Intensive Technique With and Without Lower Extremity on Functional Status of Hemiplegic Cerebral Palsy

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

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiplegic Cerebral Palsy
• Intervention / Treatment: Other: Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL); Other: Hand Arm bimanual intensive Technique (HABIT)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nadia Azhar, MS-NMPT; Phone Number: +923335281431; Email: nadia.azhar@riphah.edu.com

Study Locations

• Pakistan
  • Azad Kashmir
    • Mirpur, Azad Kashmir, Pakistan, 13230
      • Mohi Ud Din Teaching Hospital (Mirpur AJK)
      • Principal Investigator: Ayesha Mahnoor, MS-NMPT*

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hand arm Bimanual intensive Technique including Lower extremity (HABIT-IL); Hand arm Bimanual activities involving Lower extremity	Other: Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL); 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
Active Comparator: Hand Arm bimanual intensive Technique (HABIT); Hand arm Bimanual activities without involvement of lower extremity	Other: Hand Arm bimanual intensive Technique (HABIT); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 weeks
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	6 week
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.	6 weeks
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.	6 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Nadia Azhar, MS-NMPT, Riphah International University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 15, 2022
• Primary Completion (Anticipated): April 15, 2023
• Study Completion (Anticipated): April 15, 2023

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: April 28, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2022
• Last Update Submitted That Met QC Criteria: April 28, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Functional status; Hemiplegic cerebral palsy; Hand arm bimanual intensive technique
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: Ayesha Mahnoor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No