Hemiplegic Cerebral PalsyNCT05931640
Effects of Plyometric Training Versus Virtual Reality Among Hemiplegic Cerebral Palsy
A study testing Virtual Reality and Plyometric Training 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 plyometric training versus virtual reality on upper limb among 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?
- Virtual Reality and Plyometric Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 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
- 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.
Who cannot join
- 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.
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 Plyometric Training Versus Virtual Reality on Upper Limb Among Children With Hemiplegic Cerebral Palsy
The purpose of this study is to compare the effects of plyometric training versus virtual reality on upper limb among hemiplegic cerebral palsy
Read the detailed description
Cerebral palsy is a combination of disorders that makes a child's life difficult; it mainly affects the motor abilities of the child. Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. Children with cerebral palsy (CP) have decreased capacity to participate in play and sports activities. Reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. Preceding more into this disorder there are 'hemiplegic cp'. Hemiplegic cp means that one side of the body is weak, paralyzed, it includes hand, arm, shoulder, leg of the affected side. For better treatments interventions are being invented day by day but according to my research.Plyometric therapy raises force and speeds your muscle contractions' force and speeds and strength training that leads to higher explosive power needed in sports and even everyday activities. Plyometric activities can be utilized in both the lower and upper extremities, with running, jumping, or throwing a ball and virtual reality therapy (use of virtual reality technology for psychological or occupational therapy and in affecting virtual rehabilitation.); which one is better for speedy recovery.
The tools used will be QUEST (Quality of Upper Extremity Skill Tests) and Ball \& Box Test (BBT). Study will be conducted on 28 patients in two Groups. Group A will be Control Group that will be provided with Plyometric (push-ups, ball throwing, jumping, running, kicking). A protocol of 10 minutes of plyometric therapy will be given including running and jumping with ball throwing. and Group B will be Experimental Group that will be provided with Virtual Reality Therapy (VRT). A session of 12-45, twice a week, through VR goggles or VR will be given. QUEST and box \& block test will be used as tools. The Control group will be administered with 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.The Experimental group will be administered with 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.
- Conditions
- Hemiplegic Cerebral Palsy
- Being tested
- Virtual Reality, Plyometric Training
- Keywords
- Hemiplegic cerebral palsy , virtual reality , plyometric training , upper limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Plyometric Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Ball & Box Test
The Box and Block Test (BBT) measures unilateral gross manual dexterity
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 posted5 Jul 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Nosheen Manzoor, MS OPMT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931640
- Sponsor's protocol ID
- REC/RCR&AHS/23/0724
- Status last verified
- Jun 2023
- First submitted
- 26 Jun 2023
- Last updated
- 5 Jul 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 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Plyometric Training Versus Virtual Reality on Upper Limb Among Children With Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05931640
- Acronym / sponsor ID
- REC/RCR&AHS/23/0724
- Conditions
- Hemiplegic Cerebral Palsy
- Keywords
- Hemiplegic cerebral palsy , virtual reality , plyometric training , upper limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 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
- 5 Jul 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 plyometric training versus virtual reality on upper limb among hemiplegic cerebral palsy
Detailed description
Cerebral palsy is a combination of disorders that makes a child's life difficult; it mainly affects the motor abilities of the child. Cerebral palsy (CP) is a neurodevelopmental disorder characterized by abnormalities of muscle tone, movement and motor skills, and is attributed to injury to the developing brain. Children with cerebral palsy (CP) have decreased capacity to participate in play and sports activities. Reduced capacity to perform typical childhood activities contributes to low habitual physical activity and declining gross motor function in adolescence. Preceding more into this disorder there are 'hemiplegic cp'. Hemiplegic cp means that one side of the body is weak, paralyzed, it includes hand, arm, shoulder, leg of the affected side. For better treatments interventions are being invented day by day but according to my research.Plyometric therapy raises force and speeds your muscle contractions' force and speeds and strength training that leads to higher explosive power needed in sports and even everyday activities. Plyometric activities can be utilized in both the lower and upper extremities, with running, jumping, or throwing a ball and virtual reality therapy (use of virtual reality technology for psychological or occupational therapy and in affecting virtual rehabilitation.); which one is better for speedy recovery.
The tools used will be QUEST (Quality of Upper Extremity Skill Tests) and Ball \& Box Test (BBT). Study will be conducted on 28 patients in two Groups. Group A will be Control Group that will be provided with Plyometric (push-ups, ball throwing, jumping, running, kicking). A protocol of 10 minutes of plyometric therapy will be given including running and jumping with ball throwing. and Group B will be Experimental Group that will be provided with Virtual Reality Therapy (VRT). A session of 12-45, twice a week, through VR goggles or VR will be given. QUEST and box \& block test will be used as tools. The Control group will be administered with 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.The Experimental group will be administered with 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality | Experimental | Device: Virtual RealityVirtual 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. |
| Plyometric Training | Experimental | Device: Plyometric TrainingPlyometric 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Virtual RealityVirtual 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 TrainingPlyometric 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 |
Primary outcome
Quality of Upper Extremity Skill Tests
Time frame: 4 weeks
Quality of Upper Extremity Skills Test (QUEST) is an outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy
Ball & Box Test
Time frame: 4 weeks
The Box and Block Test (BBT) measures unilateral gross manual dexterity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 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 OPMT 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 Virtual Reality and Plyometric Training 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 4 inclusion and 6 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 5 Jul 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 OPMT (03236877879, nosheen.manzoor@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Upper Extremity Skill Tests (time frame: 4 weeks). The study lists 2 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 5 Jul 2023.