- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407765
Effects of Dual Task Training on Balance, Activity and Participation in Children With Cerebral Palsy
Effects of Dual Task Training With and Without Backward Walking on Balance, Activity and Participation in Children With Cerebral Palsy
Cerebral palsy is a non progressive neurodevelopmental disorder that usually effects the muscles of the patients effecting its tone, strength and eventually ability to move. Dual tasking training incorporates more than one task at a time, it can b either physical task with movement or mental tasks. Backward walking is used to challenge the proprioception.
The study is a randomized controlled trial to assess the effects of Dual task training with and without Backward walking on balance, activity and participations on children with cerebral palsy. Study will be conducted in PSRD and Rehab care. Sample will be recruited randomly and then divided into two groups control and experimental group. Control group will receive dual task training and experimental group will receive both dual task training and backward walking. This treatment would continue for 4 weeks. Patient will be assessed both at the start and end of 4 weeks. The outcome tools for assessment of balance, activity and participation will be following: Pediatric Berg Balance Scale, Time up and Go test and Participation of daily life PODCI Questionnaire. Ethical consideration will be followed and informed consent will be taken from legal guardians.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The randomized control trail includes two groups; Control and experimental group. Control group will receive Dual task training. Dual task training incorporates cognitive and motor task. motor task like waking on balance beam is combined with visual memory tasks like pointing towards an object the therapists asks, ask the patient to collect the hanging stars while different shapes are hanging above him, name the object in the picture shown to patient. This treatment will continue for 4 weeks, 4 times a week for 40 minutes.
Experimental group will receive both Dual task training and Backward walking. with the activities mentioned above patient will be asked to walk backward with any obstacle firstly with complete physiotherapist assistance and then gradually with less assistance. Secondly patients will be asked to cover a distance of 15 m through the treatment room's hallway while holding a safety bar with the hand on the unaffected side. Third, without using a safety bar, the participants were urged to walk freely. Lastly, the participants tried to walk backwards at a reasonable pace while progressively increasing their distance travelled and speed. the duration of the treatment will be the same. The patients will be assessed first at the start of treatment and then at the end of 4 weeks.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 540000
- Riphah International University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with cerebral palsy who have already received a diagnosis
- Children with GMFCS Level I-II
- Children between the ages of 6 and 12
Exclusion Criteria:
- Being unable to complete the cognitive task, which involves counting back one after each number between 0 and 100
- Posing a behavioral issue that makes it challenging to engage in the study
- Being unable to walk independently
- Children with concomitant cardiac conditions
- Any musculoskeletal surgery performed during the previous six months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Dual Task Training
This group will receive Dual task training
|
Dual task training incorporates both cognitive and motor tasks.
Tasks like walking and asking the patient to point towards objects, collect start from the objects hanging above the patient and asking the patient to name the objects shown to him/her.
This treatment will be given for 4 weeks, 4 times a week for 40 minutes.
Each task is done for 7 minutes with a 3 minutes break in between.
|
|
Experimental: Dual task training with Backward walking
This group will receive both Dual task training with Backward walking
|
This group will get both dual task training and backward walking.
For dual task training same protocol as active comparator is followed.
For backward walking; the patient is firstly asked to walk backward with complete physiotherapist assistance.
Secondly, the patient is asked to walk for 15 m through the treatment room's hallway while holding a safety bar with the hand on the unaffected side.
Third, without using a safety bar, the participants were urged to walk freely.
Lastly, the participants tried to walk backwards at a reasonable pace while progressively increasing their distance travelled and speed.
This treatment will be given for 4 weeks, 4 times a week for 40 minutes.
Each task is done for 7 minutes with a 3 minutes break in between.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric Berg Balance Scale
Time Frame: 4 weeks
|
A version of Berg's Balance Scale, the Pediatrics Balance Scale (PBS) was created as a balancing assessment for school-age children with mild to moderate motor deficits.
There is a 0.998 intra-class correlation value (ICC).
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4 weeks
|
|
Time up and go test
Time Frame: 4 weeks
|
In clinical practice, the "timed up and go" (TUG) test is a brief assessment tool used to evaluate adults' functional mobility.
The TUG test has a high level of dependability in children as well, with an ICC of 0.99 both within a session and between tests.
|
4 weeks
|
|
Participation of Daily Life PODCI Questionnaire
Time Frame: 4 weeks
|
The PODCI is a parent-reported outcome measure that evaluates children's expectations of healthcare interventions as well as their mobility, physical function, comfort, and happiness.
When assessing quality of life issues and walking function in children with cerebral palsy, the PODCI shows good validity and reliability.
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aqsa Butt, MS*, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/22/0732
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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