Ataxic Cerebral PalsyNCT06639802
Effects of Hand Arm Bimanual Intensive Therapy Including Lower Extremity on Balance and Coordination in Ataxic Cerebral Palsy
A study testing Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE) in people with Ataxic Cerebral Palsy and Coordination and Balance Disturbances, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
Ataxic cerebral palsy is an abnormal movement or posture pattern accompanied by a loss of coordinated muscle action, resulting in movements that lack proper force, rhythm, or accuracy. Ataxic CP is classified into cerebellar ataxia and ataxic diplegia. Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Ataxic Cerebral Palsy, Coordination and Balance Disturbances
- What is being tested?
- Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Apr 2024to 1 Dec 2024
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group: 6 - 15 years.
- Gender: Both males and females.
- Cerebellar Ataxic cerebral palsy [10]
- Gross motor function classification system level I and II.
- Capable of following instructions and completing all necessary tests and tasks
Who cannot join
- Uncontrolled epilepsy
- Orthopedic surgery within the past 6 months,
- Have visual, and hearing impairments (diagnosed).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Foundation University College of Physical Therapy
Rawalpindi, 46000
Furqan Ahmed Siddiqi, PhD in Rehabilitation Sciences, +923004414981, principal.fucp@fui.edu.pk
About this study
Ataxic cerebral palsy is an abnormal movement or posture pattern accompanied by a loss of coordinated muscle action, resulting in movements that lack proper force, rhythm, or accuracy. Ataxic CP is classified into cerebellar ataxia and ataxic diplegia.
In Cerebellar Ataxia, the cerebellum is hypo-plastic or malformed which impairs the integration of brain signals required for coordinating coordinated movement and balance. This study aimed to determine the effect of HABIT-ILE on the balance and coordination of children with cerebellar ataxic cerebral palsy.
Read the detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effect of HABIT-ILE on the coordination of children with cerebellar ataxic cerebral palsy.
- To determine the effect of HABIT-ILE on the balance of children with cerebellar ataxic cerebral palsy.
HYPOTHESIS:
Alternate Hypothesis:
There will be statistically significant differences in balance and coordination after HABIT-ILE in ataxic cerebral palsy.(P\>0.05)
Null Hypothesis:
There will be no statistically significant differences in balance and cooordination after HABIT-ILE in ataxic cerebral palsy.(P\>0.05)
Research Design: Experimental study. Quasi-experimental
Clinical setting: Al-Farabi Special Education Institute Islamabad Study duration: one year from Feb 2024 to 2025.
Selection Criteria:
Inclusion Criteria
- Age group: 6 - 15 years.
- Gender: Both males and females.
- Cerebellar Ataxic cerebral palsy [1]
- Gross motor function classification system level I and II.
- Capable of following instructions and completing all necessary tests and tasks
Exclusion Criteria
- Uncontrolled epilepsy
- Orthopedic surgery within the past 6 months,
- Have visual, hearing impairments (diagnosed).
Sampling technique: convenicence sampling
Outcome Measures:
- Pediatric Balance Scale [2]
- Scale for the Assessment and Rating of Ataxia [3]
- Gross Motor Function Classification System - Expanded \& Revised (GMFCS - E\&R) [4]
Data analysis techniques:
Data will be analyzed using SPSS version 20.0.0.
Significance of the study:
Cerebellar ataxic cerebral palsy is characterized by hypoplasia or malformations of the cerebellum, which hinders the integration of neural information necessary for coordination and balance.
HABIT-ILE aims to collectively target the whole body both upper and lower extremity along with trunk in intensive therapy comprising of fun and playful goal oriented tasks in order to improve balance and coordination.
So this research will find out effects of HABIT-ILE on balance and coordination of children with cerebellar ataxic cerebral palsy. Positive research outcome can contribute to better independence.
This study will add data in the limited literature of ataxic cerebral palsy.
- Being tested
- Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE)
- Keywords
- Physical Therapy Technique, coordination impairement, Ataxic Cerebral Palsy, HAnd Arm Bimanual Intensive Therapy including Lower Extremity
- Medical subject headings
- Cerebral Palsy, Ataxic, Autosomal Recessive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE)Other
HABIT-ILE is continuous intervention applied for 50-90 hours over two weeks. We will design the activities based on the findings of the initial assessments (T0) and the customized functional goals that were previously discussed with the parents (e.g., drinking on one\'s own without spilling, using one hand to hold a book while turning pages with the other, removing a t-shirt, etc.). HABIT-ILE activities are presented as games and the whole environment is arranged in such a way that children perceive the therapy as fun. Progression of difficulty depend upon success in performance of current level. Specific bi-manual activities are selected on basis of child's motor abilities, age and interest.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | HABIT-ILE is continuous intervention applied for 50-90 hours over two weeks. We will design the activities based on the findings of the initial assessments (T0) T0he customized functional goals that were previously discussed with the parents (e.g., drinking on one's own without spilling, using one hand to hold a book while turning pages with the other, removing a t-shirt, etc.).
The whole environment is arranged in such a way that children perceive the therapy as fun.
Progression of difficulty depend upon success in performance of current level. Specific bi-manual activities are selected on basis of child's motor abilities, age and interest. Receives: Other: Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
A modified version of the Berg Balance Scale, the Pediatric Balance Scale is used to evaluate school-age children\'s functional balance abilities. The 14 items on the scale have a maximum score of 56 points and are rated from 0 (lowest function) to 4 (highest function).
Measured: 2 weeks
Coordination
Method for evaluating ataxia is SARA, which consists of eight categories, each category is scored from 0 (no ataxia) to 40 (severe ataxia) based on the performance.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Apr 2024
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxic Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639802
- Sponsor's protocol ID
- FUI/CTR/2024/31
- Status last verified
- Oct 2024
- First submitted
- 20 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Hand Arm Bimanual Intensive Therapy Including Lower Extremity on Balance and Coordination in Ataxic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06639802
- Acronym / sponsor ID
- FUI/CTR/2024/31
- Keywords
- Physical Therapy Technique, coordination impairement, Ataxic Cerebral Palsy, HAnd Arm Bimanual Intensive Therapy including Lower Extremity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 10 Apr 2024 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ataxic cerebral palsy is an abnormal movement or posture pattern accompanied by a loss of coordinated muscle action, resulting in movements that lack proper force, rhythm, or accuracy. Ataxic CP is classified into cerebellar ataxia and ataxic diplegia.
In Cerebellar Ataxia, the cerebellum is hypo-plastic or malformed which impairs the integration of brain signals required for coordinating coordinated movement and balance. This study aimed to determine the effect of HABIT-ILE on the balance and coordination of children with cerebellar ataxic cerebral palsy.
Detailed description
OBJECTIVES:
The objectives of this study are:
- To determine the effect of HABIT-ILE on the coordination of children with cerebellar ataxic cerebral palsy.
- To determine the effect of HABIT-ILE on the balance of children with cerebellar ataxic cerebral palsy.
HYPOTHESIS:
Alternate Hypothesis:
There will be statistically significant differences in balance and coordination after HABIT-ILE in ataxic cerebral palsy.(P\>0.05)
Null Hypothesis:
There will be no statistically significant differences in balance and cooordination after HABIT-ILE in ataxic cerebral palsy.(P\>0.05)
Research Design: Experimental study. Quasi-experimental
Clinical setting: Al-Farabi Special Education Institute Islamabad Study duration: one year from Feb 2024 to 2025.
Selection Criteria:
Inclusion Criteria
- Age group: 6 - 15 years.
- Gender: Both males and females.
- Cerebellar Ataxic cerebral palsy [1]
- Gross motor function classification system level I and II.
- Capable of following instructions and completing all necessary tests and tasks
Exclusion Criteria
- Uncontrolled epilepsy
- Orthopedic surgery within the past 6 months,
- Have visual, hearing impairments (diagnosed).
Sampling technique: convenicence sampling
Outcome Measures:
- Pediatric Balance Scale [2]
- Scale for the Assessment and Rating of Ataxia [3]
- Gross Motor Function Classification System - Expanded \& Revised (GMFCS - E\&R) [4]
Data analysis techniques:
Data will be analyzed using SPSS version 20.0.0.
Significance of the study:
Cerebellar ataxic cerebral palsy is characterized by hypoplasia or malformations of the cerebellum, which hinders the integration of neural information necessary for coordination and balance.
HABIT-ILE aims to collectively target the whole body both upper and lower extremity along with trunk in intensive therapy comprising of fun and playful goal oriented tasks in order to improve balance and coordination.
So this research will find out effects of HABIT-ILE on balance and coordination of children with cerebellar ataxic cerebral palsy. Positive research outcome can contribute to better independence.
This study will add data in the limited literature of ataxic cerebral palsy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE)HABIT-ILE is continuous intervention applied for 50-90 hours over two weeks. We will design the activities based on the findings of the initial assessments (T0) T0he customized functional goals that were previously discussed with the parents (e.g., drinking on one's own without spilling, using one hand to hold a book while turning pages with the other, removing a t-shirt, etc.). The whole environment is arranged in such a way that children perceive the therapy as fun. Progression of difficulty depend upon success in performance of current level. Specific bi-manual activities are selected on basis of child's motor abilities, age and interest. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age group: 6 - 15 years.
- Gender: Both males and females.
- Cerebellar Ataxic cerebral palsy [10]
- Gross motor function classification system level I and II.
- Capable of following instructions and completing all necessary tests and tasks
Key exclusion criteria (3 listed)
- Uncontrolled epilepsy
- Orthopedic surgery within the past 6 months,
- Have visual, and hearing impairments (diagnosed).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE)HABIT-ILE is continuous intervention applied for 50-90 hours over two weeks. We will design the activities based on the findings of the initial assessments (T0) and the customized functional goals that were previously discussed with the parents (e.g., drinking on one\'s own without spilling, using one hand to hold a book while turning pages with the other, removing a t-shirt, etc.). HABIT-ILE activities are presented as games and the whole environment is arranged in such a way that children perceive the therapy as fun. Progression of difficulty depend upon success in performance of current level. Specific bi-manual activities are selected on basis of child's motor abilities, age and interest. | Other | Experimental group |
Primary outcome
Balance
Time frame: 2 weeks
A modified version of the Berg Balance Scale, the Pediatric Balance Scale is used to evaluate school-age children\'s functional balance abilities. The 14 items on the scale have a maximum score of 56 points and are rated from 0 (lowest function) to 4 (highest function).
Coordination
Time frame: 2 weeks
Method for evaluating ataxia is SARA, which consists of eight categories, each category is scored from 0 (no ataxia) to 40 (severe ataxia) based on the performance.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand Arm Bimanual Intensive therapy including lower extremity (HABIT-ILE) in people with Ataxic Cerebral Palsy and Coordination and Balance Disturbances, run by Foundation University Islamabad 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 3 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 15 Oct 2024. 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 Amina Aqil, MS-NPT (+923330418548, aminaaqil11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2024.