NCT05931640

Brief Summary

The purpose of this study is to compare the effects of plyometric training versus virtual reality on upper limb among hemiplegic cerebral palsy

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
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 30, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2023

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 26, 2023

Last Update Submit

June 26, 2023

Conditions

Hemiplegic Cerebral Palsy

Keywords

Hemiplegic cerebral palsy , virtual reality , plyometric training , upper limb

Outcome Measures

Primary Outcomes (2)

  • Quality of Upper Extremity Skill Tests

    Quality of Upper Extremity Skills Test (QUEST) is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy

    4 weeks

  • Ball & Box Test

    The Box and Block Test (BBT) measures unilateral gross manual dexterity

    4 weeks

Study Arms (2)

Virtual Reality

EXPERIMENTAL

Virtual Reality Therapy that includes use of VR goggle, VR headset and play station if available. Virtual games like move-pro will be used for upper limb movements. A session of 12-45 minutes, twice weekly will be done. And scoring will be done with the help of additional tools.

Device: Virtual Reality

Plyometric Training

EXPERIMENTAL

Plyometric therapy that includes 10 minutes of ball throwing, push-ups, jumping and hopping/skipping. At start intensity and speed is low, but will be increased gradually. Every score will be noted with the help of additional tools.

Device: Plyometric Training

Interventions

Virtual RealityDEVICE

Virtual Reality Therapy that includes use of VR goggle, VR headset and play station if available. Virtual games like move-pro will be used for upper limb movements. A session of 12-45 minutes, twice weekly will be done. And scoring will be done with the help of additional tools.

Virtual Reality
Plyometric TrainingDEVICE

Plyometric therapy that includes 10 minutes of ball throwing, push-ups, jumping and hopping/skipping. At start intensity and speed is low, but will be increased gradually. Every score will be noted with the help of additional tools.

Plyometric Training

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged between 6 and 12 years.
  • Lack of use of the affected upper limb.
  • Level I-III of the Manual Ability Classification System (MACS).
  • Students scoring of Modified Ashworth Scale should be 3 or less than 3 out of 5 for the same muscle groups.

You may not qualify if:

  • Low cognitive level compatible with attending a special education
  • school.
  • Presence of contractures in the affected upper limb.
  • Surgery in the six months previously.
  • Botulinum toxin in the two months previously.
  • Uncontrolled epilepsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Govt. National special education centre

Lahore, Punjab Province, 54782, Pakistan

RECRUITING

MeSH Terms

Interventions

Plyometric Exercise

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dr. Nosheen Manzoor, MS OPMT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Nosheen Manzoor, MS OPMT

CONTACT

03236877879nosheen.manzoor@riphah.edu.pk

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
SPONSOR

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

May 30, 2023

Primary Completion

August 30, 2023

Study Completion

September 20, 2023

Last Updated

July 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)