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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06407765
Other study ID # REC/RCR&AHS/22/0732
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 16, 2024
Est. completion date August 1, 2024

Study information

Verified date May 2024
Source Riphah International University
Contact Imran Amjad, PhD
Phone 9233224390125
Email Imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 44
Est. completion date August 1, 2024
Est. primary completion date July 16, 2024
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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.

Locations

Country Name City State
Pakistan Riphah international university Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

Fisher-Pipher S Pt Dpt, Kenyon LK Pt Dpt PhD Pcs, Westman M Pt Dpt. Improving balance, mobility, and dual-task performance in an adolescent with cerebral palsy: A case report. Physiother Theory Pract. 2017 Jul;33(7):586-595. doi: 10.1080/09593985.2017.1323359. Epub 2017 May 16. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pediatric Berg Balance Scale 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). 4 weeks
Primary Time up and go test 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
Primary Participation of Daily Life PODCI Questionnaire 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
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