Cerebral PalsyNCT06198153
Effects of Stationary Cycling and Progressive Functional Training in Cerebral Palsy Children
A study testing Stationary Cycling and Progressive Functional Training in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is not a progressive disease but movement problem and musculoskeletal disorders in cerebral palsy change with time. Children with CP usually with the lower limb involvement presents with muscle weakness, limited muscular control which results in muscular insufficiency, coordination and balance… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Stationary Cycling and Progressive Functional Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2023to 29 Jan 2024
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • Children with cerebral palsy (Hemiplegic)
- Age: 4 to 10 years
- Able to sit without foot or arm support
- Children with level I \& II on Gross motor function classification system
- Normal cognitive function; can understand and follow command
Who cannot join
- • Children with mental retardation.
- Visual and auditory disorders.
- History of any surgical procedure.
- Any infections, unstable seizures, etc.
- Fixed deformities or contractures of lower limbs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Stationary Cycling and Progressive Functional Training on Balance and Motor Control of Lower Extremity in Children With Cerebral Palsy
Cerebral palsy is not a progressive disease but movement problem and musculoskeletal disorders in cerebral palsy change with time. Children with CP usually with the lower limb involvement presents with muscle weakness, limited muscular control which results in muscular insufficiency, coordination and balance impairment. These impairments effect the normal activities of child in daily living. There are many children who have good cognition but poor lower limb coordination which is leading cause of disability in them and multiple factors are responsible for them like lake of awareness in parents, no time, expensive therapy program and inappropriate techniques.
Read the detailed description
The study will be randomized clinical trial and will be conducted in Bahawalpur. The study will be completed in time duration of 6 months after approval of synopsis. Non probability convenience sampling technique will be used and 22 children will be recruited in the study meeting the inclusion criteria. The participants will be divided into two groups through randomization using lottery method. Group A will perform 10-15 minutes of stationary cycle training, 3 times a week for 6 weeks. While group B will be given progressive functional training 3 times a week for 10-15 minutes for 6 weeks. Pediatrics balance scale will be used to measure functional balance skills and GMFS scale will be used to measure gross motor function. The data will be assessed at the baseline and after 6 weeks of intervention. After data collection data will be analyzed by using SPSS version 25.
- Conditions
- Cerebral Palsy
- Being tested
- Stationary Cycling, Progressive Functional Training
- Keywords
- : Balance, Cerebral palsy, Cycling,, Motor control, Functional training,
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stationary CyclingOther
In addition to the conventional physical therapy, children in this group will receive 10-15 minutes of stationary cycle training, 3 times a week for 6 weeks.
Progressive Functional TrainingOther
In addition to the conventional physical therapy, the training will follow a 6-week progressive functional training program for lower extremities. These exercises will include sit-to-stand exercise, lateral/forward step-up exercise (i.e. climbing a stair or stepping up onto a kerb), and half-knee rise exercise (i.e. rising from the ground). All exercises will be performed in 1-3 sets of 10-15 repetitions, with a 90 second rest in between the sets. Each exercise will be performed within 10-15 minutes. Training session will be given 3 times a week. During the training, intensity will be progressively increased by increasing the repetitions
| Study group | Role | What they receive |
|---|---|---|
| Stationary Cycling | Active comparator | This group will receive stationary cycling for 6 weeks. Receives: Other: Stationary Cycling |
| Progressive Functional Training | Experimental | This group will receive Progressive Functional Training programs for 6 weeks. Receives: Other: Progressive Functional Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMFM Scale
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. (13) However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item.
Scoring Key:
0= does not initiate
- initiates
- partially completes
- completes 9 (or leave blank) = not tested (NT) [used for the GMAE-2 scoring*] It is important to differentiate a true score of -0‖ (child does not initiate) from an item which is Not Tested (NT) if you are interested in using the GMFM-66 Ability Estimator (GMAE) Software. It is reliable with 95% confidence interval=0.965-0.994. The validity with 95% confidence interval=0.972-0.997
Measured: 6weeks
Pediatrics 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. (15) 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 Reliability testing performed with a sample of 20 children ages 5-15 years old with mild to moderate motor impairments showed good test-retest reliability (ICC=0.998) and good interrater reliability (ICC=0.997).
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 posted10 Jan 2024
- Study start28 Nov 2023
- Primary completion15 Jan 2024
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aneeza Maryam, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198153
- Sponsor's protocol ID
- REC/RCR&AHS/23/0751
- Status last verified
- Mar 2024
- First submitted
- 26 Dec 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ansa OEO, Mprah KW, Moses MO, Owusu I, Acheampong E. Effect of Community-Based Functional Aerobic Training on Motor Performance and Quality of Life of Children with Spastic Cerebral Palsy. Ethiop J Health Sci. 2021 Mar;31(2):381-392. doi: 10.4314/ejhs.v31i2.21.
PubMed 34158790
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Stationary Cycling and Progressive Functional Training on Balance and Motor Control of Lower Extremity in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06198153
- Acronym / sponsor ID
- REC/RCR&AHS/23/0751
- Conditions
- Cerebral Palsy
- Keywords
- : Balance, Cerebral palsy, Cycling,, Motor control, Functional training,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 10 Jan 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 not a progressive disease but movement problem and musculoskeletal disorders in cerebral palsy change with time. Children with CP usually with the lower limb involvement presents with muscle weakness, limited muscular control which results in muscular insufficiency, coordination and balance impairment. These impairments effect the normal activities of child in daily living. There are many children who have good cognition but poor lower limb coordination which is leading cause of disability in them and multiple factors are responsible for them like lake of awareness in parents, no time, expensive therapy program and inappropriate techniques.
Detailed description
The study will be randomized clinical trial and will be conducted in Bahawalpur. The study will be completed in time duration of 6 months after approval of synopsis. Non probability convenience sampling technique will be used and 22 children will be recruited in the study meeting the inclusion criteria. The participants will be divided into two groups through randomization using lottery method. Group A will perform 10-15 minutes of stationary cycle training, 3 times a week for 6 weeks. While group B will be given progressive functional training 3 times a week for 10-15 minutes for 6 weeks. Pediatrics balance scale will be used to measure functional balance skills and GMFS scale will be used to measure gross motor function. The data will be assessed at the baseline and after 6 weeks of intervention. After data collection data will be analyzed by using SPSS version 25.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stationary Cycling | Active comparator | Other: Stationary CyclingThis group will receive stationary cycling for 6 weeks. |
| Progressive Functional Training | Experimental | Other: Progressive Functional TrainingThis group will receive Progressive Functional Training programs for 6 weeks. |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Children with cerebral palsy (Hemiplegic)
Key exclusion criteria (5 listed)
- • Children with mental retardation.
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 |
|---|---|---|
| Stationary CyclingIn addition to the conventional physical therapy, children in this group will receive 10-15 minutes of stationary cycle training, 3 times a week for 6 weeks. | Other | Stationary Cycling |
| Progressive Functional TrainingIn addition to the conventional physical therapy, the training will follow a 6-week progressive functional training program for lower extremities. These exercises will include sit-to-stand exercise, lateral/forward step-up exercise (i.e. climbing a stair or stepping up onto a kerb), and half-knee rise exercise (i.e. rising from the ground). All exercises will be performed in 1-3 sets of 10-15 repetitions, with a 90 second rest in between the sets. Each exercise will be performed within 10-15 minutes. Training session will be given 3 times a week. During the training, intensity will be progressively increased by increasing the repetitions | Other | Progressive Functional Training |
Primary outcome
GMFM Scale
Time frame: 6weeks
The GMFM is a standardized observational instrument designed and validated to measure change in gross motor function over time in children with cerebral palsy. The scoring key is meant to be a general guideline. (13) However, most of the items have specific descriptors for each score. It is imperative that the guidelines contained in the manual be used for scoring each item. Scoring Key: 0= does not initiate 1. initiates 2. partially completes 3. completes 9 (or leave blank) = not tested (NT) [used for the GMAE-2 scoring*] It is important to differentiate a true score of -0‖ (child does not initiate) from an item which is Not Tested (NT) if you are interested in using the GMFM-66 Ability Estimator (GMAE) Software. It is reliable with 95% confidence interval=0.965-0.994. The validity with 95% confidence interval=0.972-0.997
Pediatrics Balance Scale
Time frame: 6 weeks
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. (15) 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 Reliability testing performed with a sample of 20 children ages 5-15 years old with mild to moderate motor impairments showed good test-retest reliability (ICC=0.998) and good interrater reliability (ICC=0.997).
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 5 Mar 2024.
- Background: PubMed 34158790Ansa OEO, Mprah KW, Moses MO, Owusu I, Acheampong E. Effect of Community-Based Functional Aerobic Training on Motor Performance and Quality of Life of Children with Spastic Cerebral Palsy. Ethiop J Health Sci. 2021 Mar;31(2):381-392. doi: 10.4314/ejhs.v31i2.21.
- 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.
Aneeza Maryam, MS* 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 Stationary Cycling and Progressive Functional Training in people with 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: finished, as of the sponsor's last update on 5 Mar 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?
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?
GMFM Scale (time frame: 6weeks). 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?
On the ClinicalTrials.gov record for NCT06198153, which also lists 1 linked publication.
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 Mar 2024.