NCT05238259

Brief Summary

Investigate the effect of wrist wheel exercise on ROM of forearm supination and its reflection on upper extremity functions of children with HCP and Compare between effects of kinesiotaping and wrist wheel on ROM of forearm supination and its reflection on upper extremity functions of children with HCP

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 2, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 14, 2022

Status Verified

February 1, 2022

Enrollment Period

3 months

First QC Date

November 2, 2021

Last Update Submit

February 11, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • Digital Goniometer used to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.

    48 children from both genders participated in this study.They assessed by Digital Goniometer to measure range of motion of forearm supination in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .

    baseline

  • Shriners Hospital Upper Extremity Evaluation (SHUEE) used to evaluate the spontaneous use of the involved extremity and evaluate the segmental alignment of the extremity while performing tasks on demand in Children with Hemiparetic Cerebral Palsy.

    48 children from both genders participated in this study.They assessed by Shriners Hospital Upper Extremity Evaluation (SHUEE) to evaluate upper extremity functions in Children with Hemiparetic Cerebral Palsy.They selected by Modified Ashworth Scale to rate muscle spasticity that all subjects selected in this study are graded 1 to 1+ for affected upper limb muscles and Manual Ability Classification System that all subjects selected in this study level II and III .

    baseline

Study Arms (2)

kinesiotaping

OTHER

Kinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant.

Device: kinesiotaping

wrist wheel

OTHER

Wrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the patient to easily roll wrist back and forth focusing on the wrist and arm

Device: wrist wheel

Interventions

Kinesio tape is the name of an adhesive tape created by Kenzo Kase in Japan in 1973. Kinesiotaping is latex-free with 100% cotton fibers that has no pharmaceutical effect, designed to mimic the elasticity properties of the muscle, skin, and fascia. These properties make it resistant and wearable for a long period, in general, 3 to 5 days at a time; it is even water resistant.

kinesiotaping

Wrist wheel is a therapy aid that exercises muscles in the wrist, forearm and shoulder. It utilizes exercises known as pronation and supination moving from pronation to supination exercises is made easy because of the wheel. It allows the pateint to easily roll wrist back and forth focusing on the wrist and arm

wrist wheel

Eligibility Criteria

Age6 Years - 8 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age ranged from six to eight years.
  • Diagnosed as HCP.
  • Children with mild upper limb spasticity in all upper limb muscles (grades 1 to 1+) according to modified Ashworth scale.
  • Children had impaired hand functions level II and III according to Manual Ability Classification System.
  • They had the ability to follow simple verbal commands regarding assessment and treatment

You may not qualify if:

  • Sever visual or auditory problems
  • Children with severe sensory at the affected upper limb.
  • Recent orthopedic surgical interference in the affected upper limb in the last six months before the study (Tenotomy or muscle transfer in the affected upper limb)
  • Recent botulinum toxin injection of the affected upper extremity muscles in the last six months before the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Abd Elfatah abd El karim Ibrahim

Cairo, Egypt

RECRUITING

Related Publications (2)

  • Shamsoddini A, Rasti Z, Kalantari M, Hollisaz MT, Sobhani V, Dalvand H, Bakhshandeh-Bali MK. The impact of Kinesio taping technique on children with cerebral palsy. Iran J Neurol. 2016 Oct 7;15(4):219-227.

    PMID: 28435631BACKGROUND
  • Allah RASTIl Z, Shamsoddini A, Dalvand H, Labaf S. The Effect of Kinesio Taping on Handgrip and Active Range of Motion of Hand in Children with Cerebral Palsy. Iran J Child Neurol. 2017 Fall;11(4):43-51.

    PMID: 29201123BACKGROUND

Central Study Contacts

Mohamed Abd Elfatah

CONTACT

Manal Salah

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 2, 2021

First Posted

February 14, 2022

Study Start

December 1, 2021

Primary Completion

February 28, 2022

Study Completion

March 1, 2022

Last Updated

February 14, 2022

Record last verified: 2022-02

Locations