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Cerebral PalsyHABIT-ILENCT07253857

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

A study testing GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity and GROUP-B , Conventional Physical Therapy in people with Cerebral Palsy and Cerebral Palsy, Spastic, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 6 to 12 years
Conditions the study is for
Cerebral Palsy, Cerebral Palsy, Spastic
What is being tested?
GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity and GROUP-B , Conventional Physical Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 sitePakistan
Study dates
20 Dec 2025to Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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 join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aruba Saeed, NMPT, PhD* contact

+92 3344399403

aruba.saeed@ubas.edu.pk

Pakistan1 site, 1 recruiting
  • Pakistan Society for Rehabilitation of Differently Abled (PSRD)

    Lahore, Punjab Province, 54660

    Recruiting

Other trials in Pakistan

About this study

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

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.

Read the 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.

Being tested
GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity, GROUP-B , Conventional Physical Therapy
Keywords
HABIT-ILE, Intensive motor therapy, Cerebral Palsy, diplegic cerebral palsy with spasticity, Spastic cerebral palsy
Medical subject headings
Cerebral Palsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called HABIT-ILE, HABIT-ILE Therapy, Hand-Arm Bimanual Intensive Therapy Including Lower Extremities

    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 TherapyOther

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

Study groups in NCT07253857
Study groupRoleWhat they receive
GROUP -A HABIT-ILE TherapyExperimentalName 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.
Receives: Other: GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity
GROUP- B Conventional Physical TherapyExperimentalThe 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.
Receives: Other: GROUP-B , Conventional Physical Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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

  2. 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

    Measured: 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

  3. ABILOCO-KIDS-CP

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

    Measured: 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

  4. 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.

    Measured: 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

  5. 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.

    Measured: 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. 6 Minute Walk Test

    It evaluates how far a person can walk in six minutes

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start20 Dec 2025
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
After recruitment into study the participants will be allocated into their respective groups utilizing the online randomizer tool.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07253857
Sponsor's protocol ID
UBAS/ERB/FoRS/25/039 Aleena
Acronym
HABIT-ILE
Status last verified
Jun 2026
First submitted
19 Nov 2025
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32375677
  • 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.

    PubMed 30446273

Questions about this trial

What is this clinical trial studying?

A study testing GROUP -A , Hand and Arm Bimanual Intensive Therapy Including Lower Extremity and GROUP-B , Conventional Physical Therapy in people with Cerebral Palsy and Cerebral Palsy, Spastic, run by Lahore University of Biological and Applied Sciences at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aleena Ishfaq, DPT (+92 3324210141, draleenaishfaqpt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gross Motor Function Measure 88 (GMFM-88) (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07253857, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.

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