NCT06930053

Brief Summary

This study will be conducted to compare between the effectiveness of Action observation therapy (AOT) and core stability training and the combination of Action observation therapy (AOT) and core stability training on hand function in hemiplegic CP

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 16, 2025

Completed
23 days until next milestone

Study Start

First participant enrolled

May 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2025

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

April 8, 2025

Last Update Submit

September 2, 2025

Conditions

Keywords

Action observation training (AOT)

Outcome Measures

Primary Outcomes (3)

  • evaluates the quality of upper extremity skill function through 33 activity items of 4 domains: dissociated movement consists of 19 items, grasp consists of 6 items, weight-bearing consists of 5 items, and protective extension consists of 3 items

    The Quality Upper Extremity Skill Test (QUEST)

    After 12 week

  • Assessment of the grip strength

    Assessment of the grip strength by using Hand and Held Dynamometer:

    After 12 week

  • Measure hand function for activities of daily living. It has 7 items include: writing, turning over 3-by-5 inch cards, picking up small common objects, simulated feeding, stacking checkers, picking up large light objects and picking up large heavy object

    Jebsen Hand Function Test

    After 12 week

Study Arms (3)

Treatment protocol in Group A, Core stability training

ACTIVE COMPARATOR

The study group will receive core stability exercises, which consist of three levels. Each level took 4 weeks. The difficulty of each level varies in proprioception, balance, and stability as it started from exercising on a stable surface "mat" and ended with unstable surface "physioball". The first simple level involves supine abdominal draw (3 sets per 20 repetitions), abdominal draw-in with a double knee to chest (3 sets/20 repetitions), and supine twist (3 sets per 20 repetitions). The second medium level involves pelvic bridging (3 sets per 3-5 repetitions) and twists with a medicine ball (3 sets per 10-20 repetitions). The third difficult level involves bridging with head-on physioball holding this position for 3-5 seconds, then slowly relaxing (3 sets per 10-20 repetitions), and prone bridging (3 sets per 3-repetitions). There was a 30-second rest between sets . The program will be applied 30 minutes a day for 3 days a week for 12 weeks. in addition to 30 minutes of a standar

Other: Core stability training

Group B, Action observation therapy

ACTIVE COMPARATOR

The examined group got 30 minutes of a standard,selected physical therapy program in addition to 30 minutes of AOT on the upper limb (total session time: 1 hour), 3 sessions per week for three consecutive months (total therapy time: 3 hours/week). Action observation was executed with therapist guidance and repeated practice (3 repetitions for each task). The child has been requested to perform the watched task with the same tool after observing a 3-minute video for each task on an adjustable monitor screen positioned one meter infront of him or her from forward, sideways, and backward directions. The therapist sat beside the child to provide verbal comments during the excursion and to guide the child's movement

Other: Action observation therapy

Group c, combination of Action observation therapy and core stability training .

ACTIVE COMPARATOR

Group c, combination of Action observation therapy and core stability training .

Other: combination of Action observation therapy and core stability training .

Interventions

The study group will receive core stability exercises, which consist of three levels. Each level took 4 weeks. The difficulty of each level varies in proprioception, balance, and stability as it started from exercising on a stable surface "mat" and ended with unstable surface "physioball". The first simple level involves supine abdominal draw (3 sets per 20 repetitions), abdominal draw-in with a double knee to chest (3 sets/20 repetitions), and supine twist (3 sets per 20 repetitions). The second medium level involves pelvic bridging (3 sets per 3-5 repetitions) and twists with a medicine ball (3 sets per 10-20 repetitions). The third difficult level involves bridging with head-on physioball holding this position for 3-5 seconds, then slowly relaxing (3 sets per 10-20 repetitions), and prone bridging (3 sets per 3-repetitions). There was a 30-second rest between sets . The program will be applied 30 minutes a day for 3 days a week for 12 weeks. in addition to 30 minutes of a standard

Treatment protocol in Group A, Core stability training

The examined group got 30 minutes of a standard,selected physical therapy program in addition to 30 minutes of AOT on the upper limb (total session time: 1 hour), 3 sessions per week for three consecutive months (total therapy time: 3 hours/week). Action observation was executed with therapist guidance and repeated practice (3 repetitions for each task). The child has been requested to perform the watched task with the same tool after observing a 3-minute video for each task on an adjustable monitor screen positioned one meter infront of him or her from forward, sideways, and backward directions. The therapist sat beside the child to provide verbal comments during the excursion and to guide the child's movement.The AOT for the examined group included six unimanual tasks and six bimanual tasks. The unimanual tasks included pressing a rubber stamp, stacking cups, drinking water from a cup, grabbing a pen, flipping cards, and putting things on a stick. The bimanual tasks were opening a bo

Group B, Action observation therapy

combination of Action observation therapy and core stability training .

Group c, combination of Action observation therapy and core stability training .

Eligibility Criteria

Age4 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Their age will be ranged from four to eight years.
  • Their grade of spasticity will be from 1 to 1+ according to Modified Ashworth scale .
  • They will be on Level I and II according to Gross Motor Functional Classification System (GMFCS) .
  • The child will be able to follow verbal commands and instructions.

You may not qualify if:

  • \- The children will be excluded if they have one of the following:
  • history of orthopedic surgery in the affected upper limb
  • Botox injection in the upper limb in the past 6 months or planned to have one during study time
  • Fixed deformities or contructures in spine. 5- A history of epileptic seizure and cardiac or respiratory problems. 6- Severe hearing and visual defect.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Abdou Ragab Abdou

Beheira, Egypt

Location

Study Officials

  • Mohamed Bedair Ibrahim, Professor of Physical Therapy

    kafr-elsheikh university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participants will not know the details of the intervention of the other groups
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Treatment protocol in Group A, Core stability training: The study group will receive core stability exercises, which consist of three levels. Each level took 4 weeks. The difficulty of each level varies in proprioception, balance, and stability as it started from exercising on a stable surface "mat" and ended with unstable surface "physioball" . Treatment protocol in Group B, Action observation therapy protocol: The examined group got 30 minutes of a standard,selected physical therapy program in addition to 30 minutes of AOT on the upper limb (total session time: 1 hour), 3 sessions per week for three consecutive months (total therapy time: 3 hours/week). Action observation was executed with therapist guidance and repeated practice (3 repetitions for each task). Treatment protocol in Group c, combination of Action observation therapy and core stability training
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 16, 2025

Study Start

May 9, 2025

Primary Completion

August 9, 2025

Study Completion

September 1, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations