Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity on Motor Function and Cognition in Children With Spastic Cerebral Palsy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Pakistan
Pakistan Society for Rehabilitation of Differently Abled (PSRD)
RECRUITING
Lahore
Contact Information
Primary
Aleena Ishfaq, DPT
draleenaishfaqpt@gmail.com
+92 3324210141
Backup
Aruba Saeed, NMPT, PhD*
aruba.saeed@ubas.edu.pk
+92 3344399403
Time Frame
Start Date: 2025-12-20
Estimated Completion Date: 2026-05
Participants
Target number of participants: 42
Treatments
Experimental: GROUP -A HABIT-ILE Therapy
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.
Experimental: GROUP- B Conventional Physical Therapy
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.
Related Therapeutic Areas
Sponsors
Leads: Lahore University of Biological and Applied Sciences

This content was sourced from clinicaltrials.gov