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

NCT05358028 | Unknown

• 1 other identifier: Ayesha Mahnoor
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Hemiplegic Cerebral Palsy

Keywords

Hand arm bimanual intensive technique; Hemiplegic cerebral palsy; Functional status

Outcome Measures

Primary Outcomes (4)

• 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 1. = initiates 2. = partially completes 3. = 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

Study Arms (2)

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

EXPERIMENTAL

Hand arm Bimanual activities involving Lower extremity

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

Hand Arm bimanual intensive Technique (HABIT)

ACTIVE COMPARATOR

Hand arm Bimanual activities without involvement of lower extremity

Other: Hand Arm bimanual intensive Technique (HABIT)

Interventions

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

Hand Arm bimanual intensive Technique (HABIT) 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

Hand Arm bimanual intensive Technique (HABIT)

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed cases of hemiplegic cerebral palsy
• GMFCS level 2,3,4
• Ashworth scale 0-2

You may not qualify if:

• History of recent orthopedic surgery
• History of seizures
• Visual impairment

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Mohi Ud Din Teaching Hospital (Mirpur AJK)

Mirpur, Azad Kashmir, 13230, Pakistan

Location

Study Officials

• Nadia Azhar, MS-NMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadia Azhar, MS-NMPT

CONTACT

+923335281431; nadia.azhar@riphah.edu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2022
• First Posted: May 3, 2022
• Study Start: May 15, 2022
• Primary Completion: April 15, 2023
• Study Completion: April 15, 2023
• Last Updated: May 3, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)