Cerebral Palsy ChildrenNCT06637579
Effects of Universal Exercise Unit Therapy With Task-oriented Training in CP Children
A study testing universal exercise unit therapy with task oriented strength training and Task-oriented training for gross motor functioning in people with Cerebral Palsy Children, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is a problem that affects the development and motor skills caused by early non-progressive central nervous system damage. Muscle rigidity, spasticity, fragility, uncontrolled movement, or a combination of these abnormalities characterized it. Therapeutic usage of the universal exercise unit is common. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy Children
- What is being tested?
- universal exercise unit therapy with task oriented strength training and Task-oriented training for gross motor functioning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2024to Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who were spastic and able to understand and follow commands. Children aged 5-15 years old. Gross Motor Function Classification System (GMFCS) level I-III. Youngsters are capable of walking and standing on their own.
Who cannot join
- Children with severe physical limitations and disabilities. Children with planned surgeries in the next 6 months. Any musculoskeletal or orthopedic conditions limiting participation in exercise programs.
- Kids with planned surgical or medical surgeries during the study period. Children with impaired cognition. Children with hearing impairment and visual impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Sialkot Medical and Physiotherapy Center
Sialkot, Punjab Province, 51310
Fasih Ahmed Rehmani, MS-OMPT, 03348005240, Fasih12190@gmail.com
Naveera Irfan, MS-NMPT
About this study
Official title: Effects of Universal Exercise Unit Therapy With Task-oriented Training on Lower Extremity Gross Motor Function and Balance in Cerebral Palsy Children
Cerebral palsy is a problem that affects the development and motor skills caused by early non-progressive central nervous system damage. Muscle rigidity, spasticity, fragility, uncontrolled movement, or a combination of these abnormalities characterized it. Therapeutic usage of the universal exercise unit is common. Also called a spider cage or monkey cage. This device helps people with motor problems, especially cerebral palsy. This metal 3-dimensional contraption uses wires, rubber bands, pulleys, weights, and belts. The goal is to engage the vestibular and proprioceptive systems, which are necessary for balance, coordination, and awareness.
Read the detailed description
A Randomized Clinical Trial (RCT) design will be employed, conducted at the Sialkot Medical and Physiotherapy Center over 10 months following synopsis approval. The anticipated sample size, accounting for a 20% attrition rate, will be 34 participants in each of the two study groups. Group A will undergo Universal Exercise Unit (UEU) therapy along with task oriented training, while Group B will receive task-oriented training for gross motor functioning. The sampling technique will be Non-probability convenience sampling, with inclusion criteria comprising children aged 5-15 diagnosed with spastic cerebral palsy, of both genders and in stable health condition. The data collection tools include the Gross Motor Function Measure 88 (GMFM 88), Trunk Impairment Scale (TIS) and pediatric balance scale. The analysis will be conducted using SPSS for Windows software version 25. Training sessions, lasting 6 weeks, will be conducted twice a week, and data will be collected before and after each session. The UEU therapy will focus on various movements facilitated by the equipment, while the task-oriented training will be personalized, targeting specific functional limitations through activities simulating daily tasks.
- Conditions
- Cerebral Palsy Children
- Being tested
- universal exercise unit therapy with task oriented strength training, Task-oriented training for gross motor functioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
universal exercise unit therapy with task oriented strength trainingOther
Leg press, Sit to stand, Half knee rise, Lateral step up, Forward step up.
Task-oriented training for gross motor functioningOther
Standing transfer (hip abduction/adduction), Stair climbing (hip extension, calf raise), Walking and gait training, Reaching and grasping activities.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A received universal exercise unit therapy with task-oriented strength training. Receives: Other: universal exercise unit therapy with task oriented strength training |
| Group B | Experimental | Group B received task-oriented training for gross motor functioning. Receives: Other: Task-oriented training for gross motor functioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM 88 (gross motor function measure)
GMFM is an assessment tool used to evaluate and measure gross motor function in CP
Measured: 6 weeks
TIS (trunk impairment scale)
TIS is a clinical assessment tool designed to evaluate trunk control
Measured: 6 weeks
Pediatric Berg Balance Scale
The Pediatric Balance Scale is used to assess functional balance skills in school-aged children
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2024
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy ChildrenStudies of the same condition, open and under way.
- 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
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Asrar Yousaf, M.phil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06637579
- Sponsor's protocol ID
- REC/RCR&AHS/24/0210
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Universal Exercise Unit Therapy With Task-oriented Training on Lower Extremity Gross Motor Function and Balance in Cerebral Palsy Children
- ClinicalTrials.gov ID
- NCT06637579
- Acronym / sponsor ID
- REC/RCR&AHS/24/0210
- Conditions
- Cerebral Palsy Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 15 Oct 2024 (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.
Cerebral palsy is a problem that affects the development and motor skills caused by early non-progressive central nervous system damage. Muscle rigidity, spasticity, fragility, uncontrolled movement, or a combination of these abnormalities characterized it. Therapeutic usage of the universal exercise unit is common. Also called a spider cage or monkey cage. This device helps people with motor problems, especially cerebral palsy. This metal 3-dimensional contraption uses wires, rubber bands, pulleys, weights, and belts. The goal is to engage the vestibular and proprioceptive systems, which are necessary for balance, coordination, and awareness.
Detailed description
A Randomized Clinical Trial (RCT) design will be employed, conducted at the Sialkot Medical and Physiotherapy Center over 10 months following synopsis approval. The anticipated sample size, accounting for a 20% attrition rate, will be 34 participants in each of the two study groups. Group A will undergo Universal Exercise Unit (UEU) therapy along with task oriented training, while Group B will receive task-oriented training for gross motor functioning. The sampling technique will be Non-probability convenience sampling, with inclusion criteria comprising children aged 5-15 diagnosed with spastic cerebral palsy, of both genders and in stable health condition. The data collection tools include the Gross Motor Function Measure 88 (GMFM 88), Trunk Impairment Scale (TIS) and pediatric balance scale. The analysis will be conducted using SPSS for Windows software version 25. Training sessions, lasting 6 weeks, will be conducted twice a week, and data will be collected before and after each session. The UEU therapy will focus on various movements facilitated by the equipment, while the task-oriented training will be personalized, targeting specific functional limitations through activities simulating daily tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: universal exercise unit therapy with task oriented strength trainingGroup A received universal exercise unit therapy with task-oriented strength training. |
| Group B | Experimental | Other: Task-oriented training for gross motor functioningGroup B received task-oriented training for gross motor functioning. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who were spastic and able to understand and follow commands. Children aged 5-15 years old. Gross Motor Function Classification System (GMFCS) level I-III. Youngsters are capable of walking and standing on their own.
Key exclusion criteria (2 listed)
- Children with severe physical limitations and disabilities. Children with planned surgeries in the next 6 months. Any musculoskeletal or orthopedic conditions limiting participation in exercise programs.
- Kids with planned surgical or medical surgeries during the study period. Children with impaired cognition. Children with hearing impairment and visual impairment.
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 |
|---|---|---|
| universal exercise unit therapy with task oriented strength trainingLeg press, Sit to stand, Half knee rise, Lateral step up, Forward step up. | Other | Group A |
| Task-oriented training for gross motor functioningStanding transfer (hip abduction/adduction), Stair climbing (hip extension, calf raise), Walking and gait training, Reaching and grasping activities. | Other | Group B |
Primary outcome
GMFM 88 (gross motor function measure)
Time frame: 6 weeks
GMFM is an assessment tool used to evaluate and measure gross motor function in CP
TIS (trunk impairment scale)
Time frame: 6 weeks
TIS is a clinical assessment tool designed to evaluate trunk control
Pediatric Berg Balance Scale
Time frame: 6 weeks
The Pediatric Balance Scale is used to assess functional balance skills in school-aged children
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy Children
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
RecruitingObservational study
Functional Benefits of Multisite Upper Limb Surgery in Children With Unilateral Cerebral Palsy (RETRO-CHIRc)
Cerebral Palsy, Hemiplegia
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.
Muhammad Asrar Yousaf, M.phil 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 universal exercise unit therapy with task oriented strength training and Task-oriented training for gross motor functioning in people with Cerebral Palsy Children, 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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 15 Oct 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, PHD (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GMFM 88 (gross motor function measure) (time frame: 6 weeks). The study lists 3 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 15 Oct 2024.