NCT06001983

Brief Summary

The purpose of this study is to compare the effects of imaginary resisted exercises versus physical resisted exercises on hand grip strength in 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
34

participants targeted

Target at P25-P50 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
15 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 21, 2023

Completed
9 days 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

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

June 14, 2023

Last Update Submit

August 18, 2023

Conditions

Keywords

Hemiplegic Cerebral Palsy, Hand Grip Strength, Imaginary Resisted Exercises, Physical Resisted Exercises.

Outcome Measures

Primary Outcomes (5)

  • Jamar Dynamometer (Hydraulic Hand Dynameter)

    The Jamar is the primary outcome measure for assessing hand grip strength

    4 weeks

  • Finger to Nose Test

    It is a part of the Fugl-Meyer Assessment for upper extremity to evaluate impairment of upper limb in stroke patients. The total movement time is used as a clinical outcome measure for quantification of movement quality and motor performance. Most commonly the person is seated and upon command moves the index fingertip back and forth between the ipsilateral knee and the tip of the nose five times, as fast, as accurate, as possible

    4 weeks

  • Purdue Peg Board Test

    It is a functional assessment tool to screen for hand dexterity. It was designed to assess fine motor hand function using three common objects, pegs, washers, and collars, to be inserted on a pegboard. With its long history and wide usage, its reliability in healthy subjects is well established because it employs tasks that resemble activities of daily living. It is economical and easy to administer

    4 weeks

  • Goniometer

    Goniometer has been the most widely used tool for measuring joint range of motion. To ensure reliable measurement, standardized, specific positions and landmarks are used to measure each joint movement

    4 weeks

  • Cell Phone Camera

    Redmi Note 7 with front camera 13 MP or above and Rear camera 48 MP or above

    4 weeks

Study Arms (2)

Imaginary resisted exercises

EXPERIMENTAL

• Handgrip exercises with the imagination of resistance in hand by getting feedback in VR Box will be given as an intervention. Stretching will be given at the beginning and the end of each session. This will include imaginary resistance exercises for handgrip by using Virtual Reality Box. Five types of different resistances will be imagined by patients by watching their own videos in VR box, which will be recorded on day one to make them familiar with the resistive objects and the resistance experienced from them by asking patients to perform 15-15 repetitions of each object. Every imaginary resistance exercise will have 15 repetitions. After performing exercises, the participants will ask to perform Finger-to-Nose Test and Purdue Pegboard Test.

Other: imaginary resisted exercises

Physical resisted exercises

EXPERIMENTAL

Handgrip exercises with physical resistance in hand will be given as an intervention. Stretching will be given at the beginning and the end of the session. 5 different types of resistances will be given to patients for making themselves familiarize themselves with the type of resistance applied by each object, that they will experience in further sessions, by asking them to perform 15-15 repetitions of each object. Every physical resistance exercise will have 15 repetitions. After performing exercises, the participants will ask to perform Finger-to-Nose Test and Purdue Pegboard Test. In physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects

Other: physical resisted exercises

Interventions

1. Imagination of squeezing a Sponge ball 15 reps 2. Imagination of Finger Exerciser 15 reps 3. Imagination of Theraband 15 reps 4. Imagination of pressing Rubber ball 15 reps 5. Imagination of pressing Hard object 15 reps

Imaginary resisted exercises

1. Resisted exercise of Squeezing a Sponge ball 15 reps 2. Resisted exercise of Finger Exerciser 15 reps 3. Resisted exercise of pulling theraband 15 reps 4. Resisted exercise of pressing Rubber ball 15 reps 5. Resisted exercise of pressing Hard object 15 reps

Physical resisted exercises

Eligibility Criteria

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

You may qualify if:

  • Congenital infantile hemiplegia.
  • 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 of previously mentioned movements.

You may not qualify if:

  • Low cognitive level compatible with attending a special education school.
  • Presence of contractures in the affected upper limb affecting the functional movement.
  • Surgery in the six months previously to the treatment.
  • Botulinum toxin in the two months previously to or during the intervention.
  • Pharmacologically 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

Study Officials

  • Dr. Nosheen Manzoor, MS OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Nosheen Manzoor, MS OMPT

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
SPONSOR

Study Record Dates

First Submitted

June 14, 2023

First Posted

August 21, 2023

Study Start

May 30, 2023

Primary Completion

August 30, 2023

Study Completion

September 20, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations