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

NCT ID: NCT05358028

Last Updated: 2022-05-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2023-04-15

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.

Conditions

Hemiplegic Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Hand arm Bimanual intensive Technique including Lower extremity (HABIT-IL)

Hand arm Bimanual activities involving Lower extremity

Group Type: EXPERIMENTAL

Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL)

Intervention Type: OTHER

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

Hand Arm bimanual intensive Technique (HABIT)

Hand arm Bimanual activities without involvement of lower extremity

Group Type: ACTIVE_COMPARATOR

Hand Arm bimanual intensive Technique (HABIT)

Intervention Type: OTHER

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

Interventions

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

Intervention Type: 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

Intervention Type: OTHER

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nadia Azhar, MS-NMPT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Mohi Ud Din Teaching Hospital (Mirpur AJK)

Mirpur, Azad Kashmir, Pakistan

Countries

Pakistan

Central Contacts

Nadia Azhar, MS-NMPT

Role: CONTACT

nadia.azhar@riphah.edu.com

+923335281431

Other Identifiers

Ayesha Mahnoor

Identifier Type: -

Identifier Source: org_study_id