NCT04679779

Brief Summary

children with cerebral palsy have impaired selective motor control and upper limb functions that affect their performance

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

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

Study Start

First participant enrolled

December 1, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2021

Completed
Last Updated

February 23, 2021

Status Verified

January 1, 2021

Enrollment Period

2 months

First QC Date

December 17, 2020

Last Update Submit

February 19, 2021

Conditions

Keywords

cerebral palsyselective motor controlupper limb coordinationvirtual reality

Outcome Measures

Primary Outcomes (1)

  • Selective voluntary motor control of upper extremity

    Test of Arm Selective Control will be used to assess selective voluntary motor control of upper extremityIt was developed to quantify the extent to which children with cerebral palsy have selective voluntary motor control. It will be used to assess movement of shoulder, elbow, forearm, wrist, finger and thumb by using simple tools for grasp items from two starting sitting positions

    6 weeks

Secondary Outcomes (2)

  • Hand grip strength

    6 weeks

  • - Upper limb function

    6 weeks

Study Arms (2)

control group

EXPERIMENTAL

receive occupational therapy program

Other: designed occupational therapy program

study group

EXPERIMENTAL

receive wii virtual reality

Other: Wii virtual reality games

Interventions

Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use.

control group

1. Bowling 2. Frisbee 3. Basketball 4. Boxing

study group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Age between 7 and 11 years
  • spasticity grade of 1+ or 2 on MAS
  • level I and II on GMFCS
  • level II and III on MACS
  • Being able to cooperate and being motivated

You may not qualify if:

  • visual or auditory problems Severe spasticity (an Ashworth spasticity score of 4 in any upper or lower extremities) Severe mental retardation surgeries for spasticity within the past 12 months, toxin injection within the past six months.
  • Structural or fixed soft tissue deformities in the affected upper extremity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egypt

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • hoda eltalawy, professor

    Cairo University

    STUDY CHAIR
  • shorouk elshennawy, professor

    Cairo University

    STUDY DIRECTOR
  • amira mahmoud, phd

    Cairo University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Control grouprecivedvDesigned occupational therapy programe including Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use. • study group will recieve Wii virtual reality games 1. Bowling 2. Frisbee 3. Basketball 4. Boxing
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 22, 2020

Study Start

December 1, 2020

Primary Completion

February 1, 2021

Study Completion

February 15, 2021

Last Updated

February 23, 2021

Record last verified: 2021-01

Locations