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

Key facts

Who runs it
Lahore University of Biological and Applied Sciences
Where
Lahore, PakistanSee the site
Trial code
Status
Recruiting
People taking part
42 people, planned
Started
20 Dec 2025
Planned end
Jun 2026
Type of study
Interventional, 2 groups
Treatments tested
  • GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity
  • GROUP-B , Conventional Physical Therapy
Record updated
18 June 2026

Who can take part

Age
6 years to 12 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 12 years old?

Where in Pakistan

  • Pakistan Society for Rehabilitation of Differently Abled (PSRD)Lahore, PakistanContact: Aleena Ishfaq, DPTTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • GROUP -A HABIT-ILE TherapyTreatment being tested

    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.

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

  • GROUP- B Conventional Physical TherapyTreatment being tested

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Effects of Hand and Arm Bimanual Intensive Therapy Including Lower Extremity on Motor Function and Cognition in Children With Spastic Cerebral Palsy
Fit questions
Built from NCT07253857, who can take part
Record updated
18 June 2026