Clinical trial NCT06198179: Effects of UP-CAT With and Without Visual Feedback in Children With CP
Official title: Effects of Upper Limb Children Action-observation Training (UP-CAT) With and Without Visual Feedback in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Cerebral palsy (CP),
Rehabilitation
Upper extremity
Activities of daily living
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 28
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be randomized controlled trial (RCT) used to measure the effects of upper limb action-observation training (UP-CAT) with and without visual feedback in children with cerebral palsy. subjects with cerebral palsy meeting pre determined inclusion and exclusion criteria will be be divided into two groups using non-probability sampling techniques.
Primary purpose: TREATMENT

Brief summary: Cerebral palsy (CP) is the most common neurological disorder of movement and/or posture and of motor function, which are due to a non-progressive interference or abnormality of the developing brain. In hemiplegic cerebral palsy (HCP), one side of the body is involved with the upper extremity more affected than the lower. HCP is treated by addressing the underlying cause and by various form of therapy to recover motor function. Motor function in hemi paretic limb particularly fine motor skill may be improved by upper limb children action-observation therapy (UP-CAT).

Detailed description: This will be randomized controlled trial. Non-probability purposive sampling technique will be used for recruiting samples for study. Children will be assessed by House Functional Classification System for hemiplegia to include in the study. Computerized randomization will be used to locate subjects in two groups, and 28 hemiplegic cerebral palsy children will be divided into 2 groups; experimental and control groups. In experimental group hemiplegic cerebral palsy children will perform upper limb exercises with visual feedback for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. In control group hemiplegic cerebral palsy children will perform upper limb activities for 5 times a week, 15 sets of daily life upper limb activities, each action will be observed for 2 minutes and executed for 2 minutes. Both groups will be assessed at the time of recruitment and at the end of 4 weeks. Data will be collected by Melbourne unilateral upper limb (MUUL) and ABILHAND-kids questionnaire. After collection of data, data will be analyzed by SPSS-25.

Eligibility criteria: Inclusion Criteria:

* Cerebral palsy children aged 5 years to 10 years at the time of recruitment.
* Both male and female
* According to Modified Ashworth scale of spasticity; score should be +1.
* Mild or moderate UL disability i.e. active use of affected UL from poor active assist use to complete spontaneous use according to House Functional Classification System grade between 4 and 8.

Exclusion Criteria:

* Individuals with the other neurological deficits
* Visual impairment.
* Children with upper limb disabilities other than hemiplegic cerebral palsy.
* Children with uncontrolled epileptic seizures in last 3 years
* Non co-operative patients.
* Previous orthopedic surgery or botulinum toxin A (BoNT-A) injection in the UL within 6 months prior to the enrolment of this study.

Primary outcomes:
measure: Melbourne Assessment of Unilateral Upper Limb Function (MUUL)
timeFrame: 4 weeks
measure: ABILHAND-Kids
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: IQRA Muhammad Afzal, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.