## Protocol Section
### Identification Module
**NCT ID:** NCT06198179

**Brief Title:** 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

#### Organization Study ID Info
**ID:** REC/RCR&AHS/23/0753
#### Organization
**Class:** OTHER
**Full Name:** Riphah International University
### Status Module
#### Completion Date
**Date:** 2024-02-05

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-01-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-01-28

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-02-05

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-01

**Type:** ACTUAL

**Status Verified Date:** 2024-01

#### Study First Post Date
**Date:** 2024-01-10
**Type:** ACTUAL
**Study First Submit Date:** 2023-12-26
**Study First Submit QC Date:** 2023-12-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Riphah International University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Cerebral Palsy

**Keywords:**

- Cerebral palsy (CP),

- Rehabilitation

- Upper extremity

- Activities of daily living

### Design Module

#### Design Info

**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.

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 28

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** these individuals will receive the upper limb children action-observation training (UP-CAT) with visual feedback

UP-CAT:

* Individual tasks like modelling compound,board games,cards,magnets,glass bead to do bracelets,painting and crafting (making a grass man,making musical instruments with cardboard),cooking (making juice cocktails,fruit skewers,chocolate fondue),building towers, making puzzles \& water games including filling a bucket with a sponge/bottle,filling \& throwing water balloons.
* To maximize the variety of the actions we included different objects (e.g.coins,bottles, stamps,modelling compound) to be grasped with different grasp types (whole hand,pinch, tripod grasp) and in different orientations of the wrist.

Visual feedback:

Mirror in front of patient will be used. After the baseline assessment,the patient in the experimental group will receive the upper limb children action-observation training with visual feedback Time of rehabilitation will be 1 hour/subject.

**Intervention Names:**

- Other: upper limb children action-observation training (UP-CAT) with visual feedback

**Label:** Experimental group

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** This will receive the upper limb children action-observation training (UP-CAT).

UP-CAT:

Following tasks will be performed by children

* Individual tasks like modelling compound,board games,cards,magnets,glass bead to do bracelets,painting and crafting (making a grass man,making musical instruments with cardboard),cooking (making juice cocktails,fruit skewers,chocolate fondue),building towers, making puzzles \& water games including filling a bucket with a sponge/bottle,filling \& throwing water balloons
* To maximize the variety of the actions we included different objects (e.g. coins,bottles, stamps,modelling compound) to be grasped with different grasp types (whole hand,pinch, tripod grasp) \& in different orientations of the wrist.After the baseline assessment,the patient in the experimental group will receive the UL children action-observation training with visual feedback Time of rehabilitation will be 1 hour per subject.

**Intervention Names:**

- Other: upper limb children action-observation training (UPCAT)

**Label:** Control group

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Control group

**Description:** upper limb children action-observation training (UPCAT) without visual Feedback

**Name:** upper limb children action-observation training (UPCAT)

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Experimental group

**Description:** upper limb children action-observation training (UP-CAT) with visual feedback: Mirror therapy as visual feedback

**Name:** upper limb children action-observation training (UP-CAT) with visual feedback

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** Melbourne Assessment of Unilateral Upper Limb Function (MUUL)

**Time Frame:** 4 weeks

**Description:** 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).

**Measure:** ABILHAND-Kids

**Time Frame:** 4 weeks

### Eligibility Module

**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.

**Healthy Volunteers:** True

**Maximum Age:** 10 Years

**Minimum Age:** 5 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** imran.amjad@riphah.edu.pk

**Name:** Imran Amjad, PhD

**Phone:** 9233224390125

**Role:** CONTACT

**Contact 2:**

**Email:** a.javeed@riphah.edu.pk

**Name:** Muhammad Asif Javed, MS

**Phone:** 923224209422

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Lahore

**Country:** Pakistan

**Facility:** Riphah International University

**State:** Punjab

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Riphah International University

**Name:** IQRA Muhammad Afzal, MS*

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### 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.

**PMID:** 29764869

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009422

- Term: Nervous System Diseases

- ID: D000001925

- Term: Brain Damage, Chronic

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5796

- Name: Cerebral Palsy

- Relevance: HIGH

- As Found: Cerebral Palsy

- ID: M13157

- Name: Paralysis

- Relevance: LOW

- As Found: Unknown

- ID: M5207

- Name: Brain Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M5202

- Name: Brain Damage, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002547

- Term: Cerebral Palsy

### Misc Info Module

- Version Holder: 2024-05-24
