Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity in Spastic Cerebral Palsy

NCT07253857 | Recruiting DMC

• 1 other identifier: UBAS/ERB/FoRS/25/039 Aleena
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral palsy (CP), particularly the spastic diplegic subtype, is characterized by motor impairments such as spasticity and mobility limitations. In addition to motor dysfunction, children with CP often experience cognitive impairments affecting decision-making, problem-solving, working memory, selective attention, and inhibitory control. These non-motor challenges contribute to reduced social interaction and quality of life. Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) has demonstrated improvements in gross motor function among children with spastic CP. However, evidence regarding its impact on cognitive outcomes remains limited. This randomized controlled trial (RCT) aims to evaluate the effects of HABIT-ILE compared with conventional therapy on both motor and cognitive functions in children with spastic diplegic CP. By addressing both upper and lower limb the research seeks to provide a comprehensive therapeutic approach that may yield more significant developmental benefits. Ultimately, the findings could inform the interventions for improving outcomes in pediatric populations affected by diplegic cerebral palsy. Participants will receive 90 hours of intervention, with assessments conducted at baseline, mid-intervention, and post-intervention. The study will investigate outcomes across motor domains and cognitive functions such as inhibitory control and working memory. Findings are expected to inform comprehensive therapeutic approaches to improve developmental outcomes and quality of life in pediatric populations affected by spastic diplegic CP.

Conditions

Cerebral Palsy; Cerebral Palsy, Spastic

Keywords

HABIT-ILE; Intensive motor therapy; Cerebral Palsy; diplegic cerebral palsy with spasticity; Spastic cerebral palsy

Outcome Measures

Primary Outcomes (6)

• Gross Motor Function Measure 88 (GMFM-88)

  It is a standardized assessment tool designed to evaluate motor function in children with cerebral palsy (CP). It consists of 88 items that measure gross motor abilities across five domains: lying \& rolling, sitting, crawling \& kneeling, standing, and walking, running \& jumping. Each domain is scored on a 4-point ordinal scale where 0 indicates the child does not initiate the movement, 1 reflects initiation with less than 10% completion, 2 represents partial completion between 10% and less than 100%, and 3 denotes full completion of the movement as intended. Higher scores means that the child can move more independently while lower scores show difficulties in movement and point to areas where therapy is needed.

  Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9

• Behavior Rating Inventory Of Executive Function-2 (BRIEF-2) Parent form

  It assesses executive function in children, including those with cerebral palsy (CP), measuring impulse control, emotional regulation, and working memory

  Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9

• ABILOCO-KIDS-CP

  This assessment tool designed to evaluate locomotion ability in children with cerebral palsy

  Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9

• ABILHAND-KIDS-CP

  it is an assessment tool designed to evaluate manual ability in children with cerebral palsy. It focuses on bimanual activities, measuring the child's ability to perform daily tasks requiring upper limb coordination.

  Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9

• Box and Block Test (BBT)

  It is assessment tool for evaluating manual dexterity in individuals with cerebral palsy. It measures gross motor coordination of the upper limbs by assessing the ability to grasp, transport, and release small blocks within a timed period.

  Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9

• 6 Minute Walk Test

  It evaluates how far a person can walk in six minutes

  Outcome will be assessed at 3 points Experimental group(HABIT-ILE);assessment will be done at baseline , after 3rd week and than after 6th week. Experimental group(conventional therapy); Outcome will be assesed at base line, after 4.5 weeks and after 9

Study Arms (2)

GROUP -A HABIT-ILE Therapy

EXPERIMENTAL

Name of intervention : Hand and Arm Bimanual Intensive Therapy Including Lower Extermity Type of intensity; intensive , activity based camp style rehabilitation program The HABIT-ILE therapy sessions will be structured to target both upper and lower limbs divided into three categories. Half of each session will focus on table-based bimanual tasks with postural challenges, performed while sitting on fitness balls or standing on balance boards to progressively increase trunk and balance control. Children will practice activities such as drawing, puzzles, crafts, and object manipulation using both hands. About one-third of the session will involve activities of daily living in standing or walking positions, including dressing, grooming, carrying trays, and retrieving items, encouraging functional mobility and postural adaptation. The remaining portion will emphasize gross motor play, such as bowling and ball games, to promote symmetrical movement and coordination.

Other: GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity

GROUP- B Conventional Physical Therapy

EXPERIMENTAL

The intervention will be delivered five times per week, with each movement repeated three to five times. Sessions will begin at low to moderate intensity and will gradually progress based on patient response. Exercises will include weight-bearing activities such as sit-to-stand transitions to strengthen quadriceps and gluteal muscles, step initiation drills to activate tibialis anterior and gastrocnemius for proper foot placement, and reaching tasks with trunk activation to improve core and upper limb strength. Additional activities will involve lateral and facilitated weight shifts to enhance hip abductor function and postural stability, trunk activation for balance, slow rhythmic movements to manage tone, and controlled handling to reduce spasticity. Cognitive therapy will be provided four times per week, lasting about 15 minutes per session. Tasks will initially focus on engagement and stimulation, progressing in complexity.

Other: GROUP-B , Conventional Physical Therapy

Interventions

GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity OTHER

Hand Arm Bimanual Intensive Therapy Including Lower Extremity being a task based intensive therapy activities will be structured according to the participants ability to preform it. The intervention incorporates structured bimanual activities that progressively increase in motor complexity, along with functional tasks that necessitate coordinated use of both hands, systematically integrating postural and lower-extremity demands. Before therapy begins, each child will participate in a baseline assessment, skilled, repetitive UE movements will be encouraged through both whole task practices where child performs the entire movement without breaking it into smaller component (15-30 min) and part task practice (for 30 sec) .The tasks will be modified to include challenges related to lower extremity and bimanual coordination in upper limb.

Also known as: HABIT-ILE, HABIT-ILE Therapy, Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

GROUP -A HABIT-ILE Therapy

GROUP-B , Conventional Physical Therapy OTHER

Conventional therapy will include stretches of lower extremity following bobath approach and cognitive exercises.

GROUP- B Conventional Physical Therapy

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosed with diplegic cerebral palsy
• CP children with manual ability level 1-3 on manual ability classification system
• Participants with gross motor function classification system level ranging from 1-3 will be included in the study.
• With an ability to grasp light objects and lift the more affected arm 15 cm above a table surface.
• Base line cognition level should be 20 or above assessed through mini mental state exam for children (MMC).

You may not qualify if:

• Uncontrolled seizures
• Recent or planned botulinum toxin injections within 6 months
• Any recent orthopedic interventions that may affect motor function
• Visual impairments impeding with treatment protocol

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (1)

Pakistan Society for Rehabilitation of Differently Abled (PSRD)

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

Related Publications (2)

• Park EY. Stability of the gross motor function classification system in children with cerebral palsy for two years. BMC Neurol. 2020 May 6;20(1):172. doi: 10.1186/s12883-020-01721-4.

  PMID: 32375677 BACKGROUND

• Craig F, Savino R, Trabacca A. A systematic review of comorbidity between cerebral palsy, autism spectrum disorders and Attention Deficit Hyperactivity Disorder. Eur J Paediatr Neurol. 2019 Jan;23(1):31-42. doi: 10.1016/j.ejpn.2018.10.005. Epub 2018 Nov 2.

  PMID: 30446273 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Aruba Saeed

  Lahore University of Biological and Applied Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleena Ishfaq, DPT

CONTACT

+92 3324210141; draleenaishfaqpt@gmail.com

Aruba Saeed, NMPT, PhD*

CONTACT

+92 3344399403; aruba.saeed@ubas.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blinding approach will be utilized only outcome accessor will be blinded of the allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After recruitment into study the participants will be allocated into their respective groups utilizing the online randomizer tool.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: December 20, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)