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

NCT ID: NCT07253857

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-20
• Study Completion Date: 2026-05-31

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.

Detailed Description

Cerebral palsy is a group of permanent movement and posture disorder caused by damage to the developing brain typically before, during or after birth. It is one of the most common neurodevelopmental disorder in childhood. Spasticity accounts for the majority of cases (around 92%), followed by dyskinesia, hypotonia, ataxia, and mixed types. Within spastic CP, three subtypes are recognized: diplegia, quadriplegia, and hemiplegia. Spastic diplegia is defined by bilateral spasticity with greater involvement of the lower limbs than the upper limbs. It leads to the development of motor and non-motor impairments. The underlying pathology typically involves corticospinal tract damage occurring before, during, or shortly after birth, often linked to prematurity, hypoxic events, or neonatal infections. The motor functions limits functional independence in more extent that cognitive functions. The primary focus of cerebral palsy treatment has been on its motor impairments, particularly spasticity and mobility challenges. According to the recent evidence the individuals with spastic diplegia often experience cognitive impairments especially deficits in executive function. There is growing awareness about these cognitive impairments but interventions for managing executive dysfunction in cerebral palsy patients are still lacking.

The rehabilitation strategies for CP traditionally emphasize physical therapy approaches such as Bobath therapy, Rood's method and Task-oriented training. The task-oriented interventions focus on practicing real-life activities to improve functional independence. More recent evidence supports that activity based approaches such as constraint induced movement therapy and goal directed training, which have shown greater effectiveness than traditional neurodevelopmental therapy. These interventions often targets the specific areas such as upper limb function while neglecting broader impairments involving lower extremities and trunk coordination.

The intensive therapy, Hand-Arm Bimanual Intensive Therapy Including Lower Extremity (HABIT-ILE) was developed to address this limitation. HABIT-ILE integrates upper and lower limb training with trunk control in a structured rehabilitation program. It emphasizes playful, repetitive, and progressively shaped voluntary movements to enhance gross motor skills, postural control, and functional independence.

HABIT-ILE is a camp based intervention in which structured tasks are provided to the participants and the intensity of each task is progressed with time. The maximum of 8-12 participants is in included in one camp. Participants will be divided in 2 groups control group (n= 21) and intervention group (n=21) sample size consisting of 42 participants. The intervention will be provided for total of 90 hour for each group. As these children have limited attention span the typical 9 hour/day intervention is reduced to 3 hour/day for 6 weeks, 5 days a week for the intervention group. For the control group the intervention session will last for 1 hour in morning and 1 hour in evening home exercise plan per day for 9 weeks, 5 days a week.

Conditions

Cerebral Palsy; Cerebral Palsy, Spastic

Keywords

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

GROUP-B , Conventional Physical Therapy

Intervention Type: OTHER

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

Interventions

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

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.

Intervention Type: OTHER

GROUP-B , Conventional Physical Therapy

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

Intervention Type: OTHER

Other Intervention Names

HABIT-ILE; HABIT-ILE Therapy; Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahore University of Biological and Applied Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aruba Saeed

Role: PRINCIPAL_INVESTIGATOR

Lahore University of Biological and Applied Sciences

Central Contacts

Aleena Ishfaq, DPT

Role: CONTACT

Phone: +92 3324210141

Email: draleenaishfaqpt@gmail.com

Aruba Saeed, NMPT, PhD*

Role: CONTACT

Phone: +92 3344399403

Email: aruba.saeed@ubas.edu.pk

References

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.

Reference Type: BACKGROUND

PMID: 32375677 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30446273 (View on PubMed)

Other Identifiers

UBAS/ERB/FoRS/25/039 Aleena

Identifier Type: -

Identifier Source: org_study_id