Cerebral PalsyNCT04995952
Comparsion of Gross Motor Task Training and Trunk Trageted Training
A study testing Gross motor training and Trunk targeted training in people with Cerebral Palsy, run by khadija liaquat at 1 site in Pakistan.
Trial summary
In this study trunk, targeted training and gross motor function training were compared their effect on functional status, range of motion, and community participation of cerebral palsy children Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Gross motor training and Trunk targeted training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2021to 15 Jul 2021
- 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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GMFCS III V
- Age 8to12 years
- Diplegic cerebral palsy
- Hypoxic brain injury
- Diagnosed with a gross motor delay by the pediatrician.
Who cannot join
- Children having a cognitive or psychiatric disorder.
- Children with known congenital limb anomaly
- Children with some chromosomal defect
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Gross Motor Task Training And Trunk Targeted Training On Balance, Range Of Motion And Community Participation In Children With Cerebral Palsy
In this study trunk, targeted training and gross motor function training were compared their effect on functional status, range of motion, and community participation of cerebral palsy children
Read the detailed description
In this project a randomized clinical trial was be conducted to determine the comparison of gross motor training technique and trunk training therapy on balance, Range of motion and community participation in children with diplegic cerebral palsy. This study aim to compare the effects of both the treatments to improve balance, quality of life and community participation. The sample was being collected according to inclusion and exclusion criteria using a convenient sampling technique within period of 6 months. The participants were be randomly allocated in two groups' .Group A received gross motor training which included sit to stand, step up and walking for 1 hour/day/3 days a week for 3 months. Group B received trunk targeted training for 1 hour/day/3 days a week for 3 months which included treadmill walking, reaching forward to the limits of stability and specific truncal activities with vibration and proprioception. The post treatment assessments was done via early assessment of balance, goniometer, and functional mobility assessment
- Conditions
- Cerebral Palsy
- Being tested
- Gross motor training, Trunk targeted training
- Keywords
- Cerebral plasy, Trunk targeted training, Gross motor trageted training, Balance
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross motor trainingBehavioural
Gross motor training activity (1 hour session, 3 times a week for 3 months). Pre ad post assessments will be taken. The Gross motor training activity will include: sit to stand, step-ups and walking. The sit to stand will be performed for 20 minutes involving 20 repetitions. We will progress from high seat sit to stand to low seat sit to stand. The step up will progress initially from a bench having low height to high height and then to stepping of stairs for 20 minutes involving 30 repetitions. The walking will occur from 3m walk and then increasing the distance
Trunk targeted trainingBehavioural
Trunk targeted training (1hour session, 3 times a week for 3 months). Pre and Post assessment will be evaluated. The trunk targeted training will include: weight supported treadmill walk, specific trunk exercises with vibration therapy and reaching forward to the limits of stability.
Specific trunk exercises will involve stride sitting to standing, sitting on a roll and moving the roll in diagonal and forward backward directions along with giving vibrational therapy on wobble board, side sitting. This activity will be performed for 30 minutes with 30 repetitions. Reaching forward to the limits of stability exercises will be performed. Asking the children to hold objects from right hand while reaching for an object on left side and vice versa. This will be performed for 20 minutes having 20 repetitions.
| Study group | Role | What they receive |
|---|---|---|
| Gross motor training activity | Experimental | Gross motor training activity It includes training of motor components of child grossly Receives: Behavioral: Gross motor training |
| Trunk targeted training | Experimental | In this training group the particpiants were given the exercises that were focused the truck muscles Receives: Behavioral: Trunk targeted training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional mobility assessment
It classifies the functional mobility of children between ages 4-18 years of age with cerebral palsy. The scale can be used to classify children's functional mobility, document change over time in the same child and to document change. The FMS rates walking ability at three specific distances, 5, 50 and 500 meters, (or 5, 50, 500 yards). This represents the child's mobility in the home, at school and in the community setting
Measured: 10 minutes
Pediatric Berg Balance Scale
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children and children with cerebral palsy. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Measured: 20 minutes
Goniometer
This is an instrument which is used to measure the range of motion
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start1 Jan 2021
- Primary completion30 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies 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
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- khadija liaquat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, khadija liaquat, Riphah International University
- Investigators
- Prof S Shakil Ur Rehman, Phd, Study director, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04995952
- Sponsor's protocol ID
- RiphahIU maryam
- Status last verified
- Jun 2023
- First submitted
- 6 Aug 2021
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- 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 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Gross Motor Task Training And Trunk Targeted Training On Balance, Range Of Motion And Community Participation In Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04995952
- Acronym / sponsor ID
- RiphahIU maryam
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral plasy, Trunk targeted training, Gross motor trageted training, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- khadija liaquatUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 9 Aug 2021 (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.
In this study trunk, targeted training and gross motor function training were compared their effect on functional status, range of motion, and community participation of cerebral palsy children
Detailed description
In this project a randomized clinical trial was be conducted to determine the comparison of gross motor training technique and trunk training therapy on balance, Range of motion and community participation in children with diplegic cerebral palsy. This study aim to compare the effects of both the treatments to improve balance, quality of life and community participation. The sample was being collected according to inclusion and exclusion criteria using a convenient sampling technique within period of 6 months. The participants were be randomly allocated in two groups' .Group A received gross motor training which included sit to stand, step up and walking for 1 hour/day/3 days a week for 3 months. Group B received trunk targeted training for 1 hour/day/3 days a week for 3 months which included treadmill walking, reaching forward to the limits of stability and specific truncal activities with vibration and proprioception. The post treatment assessments was done via early assessment of balance, goniometer, and functional mobility assessment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gross motor training activity | Experimental | Behavioral: Gross motor trainingGross motor training activity It includes training of motor components of child grossly |
| Trunk targeted training | Experimental | Behavioral: Trunk targeted trainingIn this training group the particpiants were given the exercises that were focused the truck muscles |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- GMFCS III V
- Age 8to12 years
- Diplegic cerebral palsy
- Hypoxic brain injury
- Diagnosed with a gross motor delay by the pediatrician.
Key exclusion criteria (3 listed)
- Children having a cognitive or psychiatric disorder.
- Children with known congenital limb anomaly
- Children with some chromosomal defect
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 |
|---|---|---|
| Gross motor trainingGross motor training activity (1 hour session, 3 times a week for 3 months). Pre ad post assessments will be taken. The Gross motor training activity will include: sit to stand, step-ups and walking. The sit to stand will be performed for 20 minutes involving 20 repetitions. We will progress from high seat sit to stand to low seat sit to stand. The step up will progress initially from a bench having low height to high height and then to stepping of stairs for 20 minutes involving 30 repetitions. The walking will occur from 3m walk and then increasing the distance | Behavioural | Gross motor training activity |
| Trunk targeted trainingTrunk targeted training (1hour session, 3 times a week for 3 months). Pre and Post assessment will be evaluated. The trunk targeted training will include: weight supported treadmill walk, specific trunk exercises with vibration therapy and reaching forward to the limits of stability. Specific trunk exercises will involve stride sitting to standing, sitting on a roll and moving the roll in diagonal and forward backward directions along with giving vibrational therapy on wobble board, side sitting. This activity will be performed for 30 minutes with 30 repetitions. Reaching forward to the limits of stability exercises will be performed. Asking the children to hold objects from right hand while reaching for an object on left side and vice versa. This will be performed for 20 minutes having 20 repetitions. | Behavioural | Trunk targeted training |
Primary outcome
Functional mobility assessment
Time frame: 10 minutes
It classifies the functional mobility of children between ages 4-18 years of age with cerebral palsy. The scale can be used to classify children's functional mobility, document change over time in the same child and to document change. The FMS rates walking ability at three specific distances, 5, 50 and 500 meters, (or 5, 50, 500 yards). This represents the child's mobility in the home, at school and in the community setting
Pediatric Berg Balance Scale
Time frame: 20 minutes
The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children and children with cerebral palsy. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Goniometer
Time frame: 10 minutes
This is an instrument which is used to measure the range of motion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Prof S Shakil Ur Rehman, Phd study director
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 Gross motor training and Trunk targeted training in people with Cerebral Palsy, run by khadija liaquat 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 3 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: finished, as of the sponsor's last update on 23 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional mobility assessment (time frame: 10 minutes). 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 23 Jun 2023.