Hemiplegic Cerebral PalsyNCT05878756
Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy
A study testing Functional Strength Training in people with Hemiplegic Cerebral Palsy and Mobility, run by Health Education Research Foundation (HERF) at 1 site in Pakistan.
Trial summary
The randomized control trail was to determine the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Hemiplegic Cerebral Palsy, Mobility
- What is being tested?
- Functional Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2020to 1 Dec 2020
- 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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children who didnot use the assistive device children who follow the commands children who did not treated in any other rehabilitation center
Who cannot join
- children with any other diagnosis other than CP children with fixed contractures children underwent surgery children who received Botulinum Toxin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy,A Randomized Control Trail
The randomized control trail was to determine the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.
Read the detailed description
The aim of functional physiotherapy is to train the child by emphasizing him to learn motor abilities. These motor abilities are those that are thought to be though either by children with cerebral palsy or their parents. Functional activities are learned by the repetitive practice of goal-oriented tasks in a given functional situation. This approach instead of focusing on normality, it focuses on functionality. In this way, it is very necessary for the child to practice a given task functionally rather than normally.No studies have been done to improve mobility and strength in lower limb in children with hemiplegia cerebral palsy. So for this reason, this study is conducted to investigate the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.In this way we can make these children an active participant of the society.
- Conditions
- Hemiplegic Cerebral Palsy, Mobility
- Being tested
- Functional Strength Training
- Keywords
- Cerebral palsy, Functional strength training, Mobility, GMFC, GMFM
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Strength TrainingOther
Also called conventional therapy
In addition to conventional therapy, experimental group was also given functional strength training program. Functional strength training was given as home program consisting of ten tasks.The ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball.
| Study group | Role | What they receive |
|---|---|---|
| Functional strength training | Experimental | With conventional therapy,the ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball preform from the patient 5 days per week for 4 weeks. Receives: Other: Functional Strength Training |
| Conventional therapy | Active comparator | passive and active range of motion exercises,Stretching and strengthening exercise 5 days per week for 4 weeks. Receives: Other: Functional Strength Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure (GMFM)
GMFM is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy.
Measured: Data was collected at Baseline and after 4 weeks
Gross Motor Function Classification System (GMFCS)
The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.
Measured: Data was collected at Baseline and after 4 weeks
Secondary outcomes (1)
Five time sit to stand (FTSST).
Used to asses functional lower extremity strength, transitional movements, balance, and fall risk
Measured: Data was collected at Baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start1 Jan 2020
- Primary completion1 Oct 2020
- Study completion1 Dec 2020
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.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Education Research Foundation (HERF)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mamoona Tasleem Afzal, Health Education Research Foundation (HERF)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878756
- Sponsor's protocol ID
- YIRS/1666
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 30 May 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 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Additional Functional Strength Training on Mobility in Children With Hemiplegic Cerebral Palsy,A Randomized Control Trail
- ClinicalTrials.gov ID
- NCT05878756
- Acronym / sponsor ID
- YIRS/1666
- Conditions
- Hemiplegic Cerebral Palsy, Mobility
- Keywords
- Cerebral palsy, Functional strength training, Mobility, GMFC, GMFM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Health Education Research Foundation (HERF)University, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 26 May 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 randomized control trail was to determine the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.
Detailed description
The aim of functional physiotherapy is to train the child by emphasizing him to learn motor abilities. These motor abilities are those that are thought to be though either by children with cerebral palsy or their parents. Functional activities are learned by the repetitive practice of goal-oriented tasks in a given functional situation. This approach instead of focusing on normality, it focuses on functionality. In this way, it is very necessary for the child to practice a given task functionally rather than normally.No studies have been done to improve mobility and strength in lower limb in children with hemiplegia cerebral palsy. So for this reason, this study is conducted to investigate the effects of additional functional Strength Training on mobility in Children with Hemiplegic Cerebral Palsy.In this way we can make these children an active participant of the society.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional strength training | Experimental | Other: Functional Strength TrainingWith conventional therapy,the ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball preform from the patient 5 days per week for 4 weeks. |
| Conventional therapy | Active comparator | Other: Functional Strength Trainingpassive and active range of motion exercises,Stretching and strengthening exercise 5 days per week for 4 weeks. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- children who didnot use the assistive device children who follow the commands children who did not treated in any other rehabilitation center
Key exclusion criteria (1 listed)
- children with any other diagnosis other than CP children with fixed contractures children underwent surgery children who received Botulinum Toxin
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 |
|---|---|---|
| Functional Strength TrainingAlso: conventional therapyIn addition to conventional therapy, experimental group was also given functional strength training program. Functional strength training was given as home program consisting of ten tasks.The ten tasks were STS, one leg standing, weight shifting(from one side of body to other), step-ups, lateral step-ups, squatting against wall, picking an object from standing position, walking forward, walking backward and kicking the ball. | Other | Conventional therapy, Functional strength training |
Primary outcome
Gross Motor Function Measure (GMFM)
Time frame: Data was collected at Baseline and after 4 weeks
GMFM is used to evaluate change that occurs over time in the gross motor function of children with cerebral palsy.
Gross Motor Function Classification System (GMFCS)
Time frame: Data was collected at Baseline and after 4 weeks
The GMFCS, or Gross Motor Function Classification System, is a five-level classification that differentiates children with cerebral palsy based on the child's current gross motor abilities, limitations in gross motor function, and need for assistive technology and wheeled mobility.
1 secondary outcome
Five time sit to stand (FTSST).
Time frame: Data was collected at Baseline and after 4 weeks
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 30 May 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Strength Training in people with Hemiplegic Cerebral Palsy and Mobility, run by Health Education Research Foundation (HERF) 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 1 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 30 May 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?
Gross Motor Function Measure (GMFM) (time frame: Data was collected at Baseline and after 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 30 May 2023.