Hemiplegic Cerebral PalsyNCT06001983
Effect of Imaginary Resisted Therapy Versus Physical Resisted Therapy on Hemiplegic Cerebral Palsy
A study testing imaginary resisted exercises and physical resisted exercises in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy
- What is being tested?
- imaginary resisted exercises and physical resisted exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 30 May 2023to 20 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Govt. National special education centre
Lahore, Punjab Province, 54782
Naseer Khan, 03076913927
About this study
Official title: Effects of Imaginary Resisted Exercises Versus Physical Resisted Exercises on Hand Grip Strength in Children With Hemiplegic Cerebral Palsy
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
Read the 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.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- imaginary resisted exercises, physical resisted exercises
- Keywords
- Hemiplegic Cerebral Palsy, Hand Grip Strength, Imaginary Resisted Exercises, Physical Resisted Exercises.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaginary resisted exercisesOther
- 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
physical resisted exercisesOther
- 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: physical resisted exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jamar Dynamometer (Hydraulic Hand Dynameter)
The Jamar is the primary outcome measure for assessing hand grip strength
Measured: 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
Measured: 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
Measured: 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
Measured: 4 weeks
Cell Phone Camera
Redmi Note 7 with front camera 13 MP or above and Rear camera 48 MP or above
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start30 May 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion20 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Nosheen Manzoor, MS OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001983
- Sponsor's protocol ID
- REC/RCR & AHS/23/0721
- Status last verified
- Aug 2023
- First submitted
- 14 Jun 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Imaginary Resisted Exercises Versus Physical Resisted Exercises on Hand Grip Strength in Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06001983
- Acronym / sponsor ID
- REC/RCR & AHS/23/0721
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Hemiplegic Cerebral Palsy, Hand Grip Strength, Imaginary Resisted Exercises, Physical Resisted Exercises.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 20 Sep 2023 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Imaginary resisted exercises | Experimental | Other: imaginary resisted exercises• 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. |
| Physical resisted exercises | Experimental | Other: physical resisted exercisesHandgrip 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imaginary resisted exercises1. 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 | Other | Imaginary resisted exercises |
| physical resisted exercises1. 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 | Other | Physical resisted exercises |
Primary outcome
Jamar Dynamometer (Hydraulic Hand Dynameter)
Time frame: 4 weeks
The Jamar is the primary outcome measure for assessing hand grip strength
Finger to Nose Test
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Time frame: 4 weeks
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
Time frame: 4 weeks
Redmi Note 7 with front camera 13 MP or above and Rear camera 48 MP or above
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Hemiplegic Cerebral Palsy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
Not yet recruiting
Effects of Upper Extremity Physiotherapy and Home Exercises on Functional Outcomes in Individuals With Stroke
Stroke
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
Active, not recruiting
Virtual Reality Vs Postural Control Training in Children With Cerebral Palsy
Children With Hemiplegic cp
Recruiting
Neuro-MoD: Neuroplasticity With Motor Development
Perinatal Brain Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Nosheen Manzoor, MS OMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing imaginary resisted exercises and physical resisted exercises in people with Hemiplegic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Nosheen Manzoor, MS OMPT (03236877879, Nosheenmanzoor_444@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Jamar Dynamometer (Hydraulic Hand Dynameter) (time frame: 4 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.