Effects of UP-CAT With and Without Visual Feedback in Children With CP

Cerebral Palsy Clinical Trial

Official title:

Effects of Upper Limb Children Action-observation Training (UP-CAT) With and Without Visual Feedback in Children With Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06198179
• Other study ID #: REC/RCR&AHS/23/0753
• Status: Completed
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: February 5, 2024

Study information

• Verified date: June 2024
• Source: Riphah International University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 5, 2024
• Est. primary completion date: February 5, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Other:
• upper limb children action-observation training (UPCAT)
upper limb children action-observation training (UPCAT) without visual Feedback
• upper limb children action-observation training (UP-CAT) with visual feedback
upper limb children action-observation training (UP-CAT) with visual feedback: Mirror therapy as visual feedback

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)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melbourne Assessment of Unilateral Upper Limb Function (MUUL)	The MUUL is an evaluative tool that measures unilateral upper extremity quality of movement in children with neurological impairments aged from 5 to 15 years. MUUL is a criterion-referenced test based on 16 items scored on a 3- to 5-point ordinal scale comprising tasks that are representative of the most important components of unilateral UL function	4 weeks
Primary	ABILHAND-Kids	The ABILHAND-Kids is a short questionnaire that measures 21 mainly bimanual daily activities referred to the activity domain of the ICF. The difficulty experienced by the child to perform the required tasks is scored by a parent on a 3-point ordinal scale (impossible, difficult, and easy).	4 weeks