Hemiplegic Cerebral PalsyNCT05358028
Effect of Hand Arm Bimanual Intensive Technique Including Lower Extremity (HABIT-IL) on Hemiplegic Cerebral Palsy
A study testing Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL) and Hand Arm bimanual intensive Technique (HABIT) in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to determine the functional status of upper extremity using HABIT \& HABIT-ILE. And to compare the effects of HABIT with and without lower extremity technique on functional status of hemiplegic cerebral palsy Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL) and Hand Arm bimanual intensive Technique (HABIT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 15 May 2022to 15 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed cases of hemiplegic cerebral palsy
- GMFCS level 2,3,4
- Ashworth scale 0-2
Who cannot join
- History of recent orthopedic surgery
- History of seizures
- Visual impairment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Mohi Ud Din Teaching Hospital (Mirpur AJK)
Mirpur, Azad Kashmir, 13230
Ayesha Mahnoor, MS-NMPT*
About this study
Official title: Comparison of Hand Arm Bimanual Intensive Technique With and Without Lower Extremity on Functional Status of Hemiplegic Cerebral Palsy
The aim of this study is to determine the functional status of upper extremity using HABIT \& HABIT-ILE. And to compare the effects of HABIT with and without lower extremity technique on functional status of hemiplegic cerebral palsy
Read the detailed description
Hemiplegic cerebral palsy children have impairments in bimanual coordination above and beyond their unilateral impairments .Hand-arm bimanual intensive therapy tends to show a constructive impact on hand function in children with hemi paretic cerebral palsy.
Hand-Arm Bimanual Intensive Therapy (HABIT) designed for children with unilateral CP, which when combines bimanual upper extremity training with activities involving the trunk and lower extremities making it HABIT-ILE.
A bimanual training program that continuously focusses on postural control and lower limb functional activity is all covered in HABIT-ILE Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) involves the concepts of motor skill learning and intensive training to both the UE and LE.
However it is not known that whether combined upper and lower extremity training in an intensive protocol is more efficacious or not thus Rationale of this study would be to figure out that if an intensive protocol is devised involving upper and lower extremities both would it be more product full or not. This study would be significant in a way that we know cerebral palsy is a lifelong challenging condition for both children and their caregivers thus new and emerging treatments can be fruitful for progression.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL), Hand Arm bimanual intensive Technique (HABIT)
- Keywords
- Hand arm bimanual intensive technique, Hemiplegic cerebral palsy, Functional status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL)Other
HABIT-ILE along with the conventional Bobath treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities.
Functional task as maintaining ADL:
i.Eating with spoon while standing ii. Combing hair while standing. iii. Counting cards while standing and putting them in box. Standing and walking I. standing with support of upper extremity II. walking with the help walkers III. walking on parallel bar playing activities: I. playing with cards while standings II. taking toys out of box and putting them in other box while standing III. grasping a fixed rod by hand and trying to maintain balance on physio stability ball
Hand Arm bimanual intensive Technique (HABIT)Other
HAIBT along with the conventional Bobath treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities HAIBT along with the conventional Bobth treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities
Playing activities on table:
- building towers with Lego blocks, II. Holding book by one hand and turning pages , III. Playing games with cards, IV. Drawing random impressions on paper, V. taking toys out of one box and placing them in other box one by one
Activities of daily living :
- eating with spoon from bowel II. combing hair while sitting, III. opening of bottle cap for drinking water Age appropriate video games while sitting will be provided according to the ease of children
| Study group | Role | What they receive |
|---|---|---|
| Hand arm Bimanual intensive Technique including Lower extremity (HABIT-IL) | Experimental | Hand arm Bimanual activities involving Lower extremity Receives: Other: Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL) |
| Hand Arm bimanual intensive Technique (HABIT) | Active comparator | Hand arm Bimanual activities without involvement of lower extremity Receives: Other: Hand Arm bimanual intensive Technique (HABIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
six minute walk test
The object of this test is to walk as far as possible for 6 minutes. the patient will walk back and forth in this hallway. Six minutes is a long time to walk, so the patient will be exerting. he will probably get out of breath or become exhausted. patients are permitted to slow down, to stop, and to rest as necessary. he may lean against the wall while resting, but resume walking as soon as patients are able. the patient will be walking back and forth around the cones. the patient should pivot briskly around the cones and continue back the other way without hesitation Predictive equation for males: 6 Minute Walk Distance (m) = 867 - (5.71 age, yrs) + (1.03 height, cm) Predictive equation for females: 6 Minute Walk Distance(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI).
Measured: 6 weeks
Gross motor function measure
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline.
SCORING KEY 0 = does not initiate
- = initiates
- = partially completes
- = completes NT = Not tested
Measured: 6 week
Box And Block
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity. During the performance of the BBT, the evaluator should be aware of whether the client's fingertips are crossing the partition. Blocks should be counted only when this condition is respected. Furthermore, if two blocks are transferred at once, only one block will be counted.
Measured: 6 weeks
Assisting hand Assessment scale
AHA assesses the child's spontaneous and regular way of handling objects during play in natural settings, and is therefore a measure of usual everyday performance. AHA is appropriate to use for children with hemiplegic cerebral palsy (CP). 22 items consisting of observable actions, e.g. manipulates, varies grips, releases, and holds. The session is recorded and scored based on the 22 items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective).
The range of sum scores is 22-88 points.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start15 May 2022 (estimated)
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadia Azhar, MS-NMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358028
- Sponsor's protocol ID
- Ayesha Mahnoor
- Status last verified
- Apr 2022
- First submitted
- 28 Apr 2022
- Last updated
- 3 May 2022
- 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 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hand Arm Bimanual Intensive Technique With and Without Lower Extremity on Functional Status of Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05358028
- Acronym / sponsor ID
- Ayesha Mahnoor
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Hand arm bimanual intensive technique, Hemiplegic cerebral palsy, Functional status
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 May 2022 (estimated)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 3 May 2022 (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.
The aim of this study is to determine the functional status of upper extremity using HABIT \& HABIT-ILE. And to compare the effects of HABIT with and without lower extremity technique on functional status of hemiplegic cerebral palsy
Detailed description
Hemiplegic cerebral palsy children have impairments in bimanual coordination above and beyond their unilateral impairments .Hand-arm bimanual intensive therapy tends to show a constructive impact on hand function in children with hemi paretic cerebral palsy.
Hand-Arm Bimanual Intensive Therapy (HABIT) designed for children with unilateral CP, which when combines bimanual upper extremity training with activities involving the trunk and lower extremities making it HABIT-ILE.
A bimanual training program that continuously focusses on postural control and lower limb functional activity is all covered in HABIT-ILE Hand-arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) involves the concepts of motor skill learning and intensive training to both the UE and LE.
However it is not known that whether combined upper and lower extremity training in an intensive protocol is more efficacious or not thus Rationale of this study would be to figure out that if an intensive protocol is devised involving upper and lower extremities both would it be more product full or not. This study would be significant in a way that we know cerebral palsy is a lifelong challenging condition for both children and their caregivers thus new and emerging treatments can be fruitful for progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand arm Bimanual intensive Technique including Lower extremity (HABIT-IL) | Experimental | Other: Hand Arm Bimanual Intensive Technique including Lower Extremity (HABIT-IL)Hand arm Bimanual activities involving Lower extremity |
| Hand Arm bimanual intensive Technique (HABIT) | Active comparator | Other: Hand Arm bimanual intensive Technique (HABIT)Hand arm Bimanual activities without involvement of lower extremity |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Diagnosed cases of hemiplegic cerebral palsy
- GMFCS level 2,3,4
- Ashworth scale 0-2
Key exclusion criteria (3 listed)
- History of recent orthopedic surgery
- History of seizures
- Visual impairment
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 Technique including Lower Extremity (HABIT-IL)HABIT-ILE along with the conventional Bobath treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities. Functional task as maintaining ADL: i.Eating with spoon while standing ii. Combing hair while standing. iii. Counting cards while standing and putting them in box. Standing and walking I. standing with support of upper extremity II. walking with the help walkers III. walking on parallel bar playing activities: I. playing with cards while standings II. taking toys out of box and putting them in other box while standing III. grasping a fixed rod by hand and trying to maintain balance on physio stability ball | Other | Hand arm Bimanual intensive Technique including Lower extremity (HABIT-IL) |
| Hand Arm bimanual intensive Technique (HABIT)HAIBT along with the conventional Bobath treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities HAIBT along with the conventional Bobth treatment will be performed for 30 days in the form of groups for 3 hours, children will be performing individual activities Playing activities on table: I. building towers with Lego blocks, II. Holding book by one hand and turning pages , III. Playing games with cards, IV. Drawing random impressions on paper, V. taking toys out of one box and placing them in other box one by one Activities of daily living : I. eating with spoon from bowel II. combing hair while sitting, III. opening of bottle cap for drinking water Age appropriate video games while sitting will be provided according to the ease of children | Other | Hand Arm bimanual intensive Technique (HABIT) |
Primary outcome
six minute walk test
Time frame: 6 weeks
The object of this test is to walk as far as possible for 6 minutes. the patient will walk back and forth in this hallway. Six minutes is a long time to walk, so the patient will be exerting. he will probably get out of breath or become exhausted. patients are permitted to slow down, to stop, and to rest as necessary. he may lean against the wall while resting, but resume walking as soon as patients are able. the patient will be walking back and forth around the cones. the patient should pivot briskly around the cones and continue back the other way without hesitation Predictive equation for males: 6 Minute Walk Distance (m) = 867 - (5.71 age, yrs) + (1.03 height, cm) Predictive equation for females: 6 Minute Walk Distance(m) = 525 - (2.86 age, yrs) + (2.71 height, cm) - (6.22 BMI).
Gross motor function measure
Time frame: 6 week
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. SCORING KEY 0 = does not initiate 1. = initiates 2. = partially completes 3. = completes NT = Not tested
Box And Block
Time frame: 6 weeks
The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the client to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. Clients are scored based on the number of blocks transferred from one compartment to the other compartment in 60 seconds. Score each hand separately. Higher scores are indicative of better manual dexterity. During the performance of the BBT, the evaluator should be aware of whether the client's fingertips are crossing the partition. Blocks should be counted only when this condition is respected. Furthermore, if two blocks are transferred at once, only one block will be counted.
Assisting hand Assessment scale
Time frame: 6 weeks
AHA assesses the child's spontaneous and regular way of handling objects during play in natural settings, and is therefore a measure of usual everyday performance. AHA is appropriate to use for children with hemiplegic cerebral palsy (CP). 22 items consisting of observable actions, e.g. manipulates, varies grips, releases, and holds. The session is recorded and scored based on the 22 items on a 4-point rating scale evaluating quality of the performance (1=does not do, 4=effective). The range of sum scores is 22-88 points.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- 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. This study is not recruiting at the moment.
Nadia Azhar, MS-NMPT principal investigator
Riphah International University
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 Technique including Lower Extremity (HABIT-IL) and Hand Arm bimanual intensive Technique (HABIT) in people with Hemiplegic Cerebral Palsy, run by Riphah International University 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 3 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: status not confirmed, as of the sponsor's last update on 3 May 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nadia Azhar, MS-NMPT (+923335281431, nadia.azhar@riphah.edu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
six minute walk test (time frame: 6 weeks). The study lists 4 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 3 May 2022.