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Effect of Imaginary Resisted Therapy Versus Physical Resisted Therapy on Hemiplegic Cerebral Palsy

Primary Purpose

Hemiplegic Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
imaginary resisted exercises
physical resisted exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Cerebral Palsy focused on measuring Hemiplegic Cerebral Palsy, Hand Grip Strength, Imaginary Resisted Exercises, Physical Resisted Exercises.

Eligibility Criteria

6 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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

Sites / Locations

  • Govt. National special education centreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Imaginary resisted exercises

Physical resisted exercises

Arm Description

• 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.

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

Outcomes

Primary Outcome Measures

Jamar Dynamometer (Hydraulic Hand Dynameter)
The Jamar is the primary outcome measure for assessing hand grip strength
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
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
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
Cell Phone Camera
Redmi Note 7 with front camera 13 MP or above and Rear camera 48 MP or above

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
August 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06001983
Brief Title
Effect of Imaginary Resisted Therapy Versus Physical Resisted Therapy on Hemiplegic Cerebral Palsy
Official Title
Effects of Imaginary Resisted Exercises Versus Physical Resisted Exercises on Hand Grip Strength in Children With Hemiplegic Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
August 30, 2023 (Anticipated)
Study Completion Date
September 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
Detailed Description
Cerebral palsy (CP) is one of the most frequent causes of motor disability in children. CP is a group of permanent disorders of the development of movement and posture, causing activity limitations that are attributed to non-progressive disturbances that occurred in the developing fetal or infant brain. The risk factors for CP can be divided into pre-conception, prenatal, perinatal and postnatal ones. Twenty five percent of children with CP have spastic hemiplegia. Hemiplegic cerebral palsy falls in anatomic classification of cerebral palsy which affects only one side of body. Children who have hemiplegic cerebral palsy have absolutely no use of one side of the body. This means their shoulder; arm, hand, leg and foot are all completely paralyzed. So, in order to improve strength in upper extremity and hand, resistance exercises are used. The study will be a randomized control trial. Patients will be recruited into two groups using simple random assignment. Non probability convenient sampling will be used. Data will be collected from patients with hemiplegic cerebral palsy by using Jamar dynamometer which is consider as a gold standard in measuring repetitive gripping, goniometer for range of motion and Finger to nose test to access the upper extremity function in stroke patient Those who will meet the inclusion criteria will be recruited. Group A will receive imaginary resisted exercise therapy 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. Group B will receive physical resisted exercise therapy in which 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. At the end of each session patient will perform finger to nose test and Purdue peg board test. After collecting data from the defined setting, it will be entered and analyzed using statistical package for social sciences (SPSS) for Windows Software, version 21.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Cerebral Palsy
Keywords
Hemiplegic Cerebral Palsy, Hand Grip Strength, Imaginary Resisted Exercises, Physical Resisted Exercises.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imaginary resisted exercises
Arm Type
Experimental
Arm Description
• 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.
Arm Title
Physical resisted exercises
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
imaginary resisted exercises
Intervention Description
Imagination of squeezing a Sponge ball 15 reps Imagination of Finger Exerciser 15 reps Imagination of Theraband 15 reps Imagination of pressing Rubber ball 15 reps Imagination of pressing Hard object 15 reps
Intervention Type
Other
Intervention Name(s)
physical resisted exercises
Intervention Description
Resisted exercise of Squeezing a Sponge ball 15 reps Resisted exercise of Finger Exerciser 15 reps Resisted exercise of pulling theraband 15 reps Resisted exercise of pressing Rubber ball 15 reps Resisted exercise of pressing Hard object 15 reps
Primary Outcome Measure Information:
Title
Jamar Dynamometer (Hydraulic Hand Dynameter)
Description
The Jamar is the primary outcome measure for assessing hand grip strength
Time Frame
4 weeks
Title
Finger to Nose Test
Description
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
Time Frame
4 weeks
Title
Purdue Peg Board Test
Description
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
Time Frame
4 weeks
Title
Goniometer
Description
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
Time Frame
4 weeks
Title
Cell Phone Camera
Description
Redmi Note 7 with front camera 13 MP or above and Rear camera 48 MP or above
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Nosheen Manzoor, MS OMPT
Phone
03236877879
Email
Nosheenmanzoor_444@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Nosheen Manzoor, MS OMPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Govt. National special education centre
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54782
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naseer Khan
Phone
03076913927

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Imaginary Resisted Therapy Versus Physical Resisted Therapy on Hemiplegic Cerebral Palsy

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