Spastic Cerebral PalsyNCT06407869
Effects of Functional Progressive Strength Training in Children With Spastic Cerebral Palsy
A study testing Functional Progressive Strength Training in people with Spastic Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study focuses on the effects of Functional Progressive Strength Training (FPST) on children with spastic cerebral palsy, a condition characterized by increased muscle tone that affects movement. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- Functional Progressive Strength Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jun 2024to 25 Aug 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 6 to 12 years
- Children had to be able to understand and follow instructions
- Diplegic CP
- GMFSC I, II, III
Who cannot join
- Treatment with botulinum toxin A in lower limb.
- Rhizotomy done 6 months before the study.
- Children with unstable seizures will be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Functional Progressive Strength Training on Gait Parameters and Walking Capacity in Children With Spastic Cerebral Palsy
This study focuses on the effects of Functional Progressive Strength Training (FPST) on children with spastic cerebral palsy, a condition characterized by increased muscle tone that affects movement. Spastic cerebral palsy is one type of cerebral palsy, with others including dyskinetic, which involves involuntary movements, and ataxic, which affects coordination. FPST differs from traditional strength training by incorporating exercises that replicate everyday activities to integrate strength use in daily movements. The study uses an experimental design with participants aged 6-12 years, recruited from specialized centers. They are randomly assigned to either a treatment group receiving FPST or a control group receiving standard care. The study aims to measure improvements in gait and mobility, assessed through various tools like step and stride length, cadence, and gait speed, alongside caregiver reports and direct observations. Statistical analyses will determine the effectiveness of FPST in enhancing motor function and walking capacity in these children.
Read the detailed description
In the outlined study, participants who fit the necessary inclusion and exclusion criteria are asked to provide written informed consent before taking part. The randomization process involves each participant drawing a number from a box: those who draw number one are placed in Group A (experimental group), while those drawing number two are placed in Group B (control group).
Group A undergoes a specialized treatment approach called Functional Progressive Resistance Exercise (FPRE), in addition to receiving conventional treatment. The FPRE regimen starts with a three-minute warm-up that includes range of motion mobilization and stretching exercises. This is followed by a series of resistance exercises, such as sit-to-stand activities, which increase in intensity over a six-week period, targeting specific percentages of body weight. The participants then engage in half-kneeling, standing up, and side-step-up exercises for 20 minutes each, with rest intervals. The session concludes with a two-minute cooldown. The protocol is designed to gradually increase the load carried by the participants, scaling up to five times, then 10 times, and eventually 15 times the initial weight, with a minimum of one minute of rest between sets. The exercises are calibrated through trial and error to find the maximum load that can be lifted for the defined number of repetitions and sets.
Group B participants receive conventional physical therapy aimed at maintaining muscle flexibility and improving motor function. Their routine includes an hour-long session three times a week, consisting of stretching exercises focused on muscles prone to tightness, such as the Achilles tendons, hamstrings, hip flexors, and adductors. Strength training targets specific muscle groups including hip flexors, knee extensors, and ankle dorsiflexors. The gait training in Group B starts in a controlled environment, such as walking between parallel bars, and progresses to more complex tasks like walking unassisted in open spaces, navigating different floor surfaces, and moving through obstacle-laden paths.
Both groups are reassessed after 12 weeks to evaluate the impact of their respective interventions on gait parameters and walking capacity, using a combination of direct observation, caregiver reports, and standardized assessment tools. The study aims to ascertain the relative efficacy of these two approaches in enhancing mobility and quality of life for children with spastic cerebral palsy.
- Conditions
- Spastic Cerebral Palsy
- Being tested
- Functional Progressive Strength Training, Control
- Keywords
- Spastic CP, Functional Progressive Strength 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.
Functional Progressive Strength TrainingOther
The Functional Progressive Resistance Exercise (FPRE) protocol is designed to improve functional strength through structured workouts. It begins with a 3-minute warmup involving stretching and range of motion exercises, followed by progressively intense sit-to-stand exercises over six weeks. Participants also perform half-kneeling, standing up, and side-step-up exercises, with 20 minutes of total activity and rest intervals. The session ends with a 2-minute cooldown. Weights are gradually increased up to 15 times the initial load, with a minimum of one-minute rest between sets. The regimen is tailored through trial and error to find the maximum load participants can effectively manage.
ControlOther
conventional physical therapy techniques will be applied
| Study group | Role | What they receive |
|---|---|---|
| Functional Progressive Strength Training | Experimental | group of 20 children with spastic cerebral palsy on which FPST techniques including 3 or 4 PRT sessions per week for 12 weekswill be applied. Receives: Other: Functional Progressive Strength Training |
| Control | Other | group of 20 children with spastic cerebral palsy on which conventional physical therapy techniques will be applied Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Parameters
To assess gait parameters in a study, four tools are utilized: step length, measuring the distance between alternating heel strikes; stride length, measuring the distance between two heel strikes of the same extremity; cadence, counting the number of steps taken; and gait speed, timing the duration to cover a 5-meter distance with a stopwatch.
Measured: 12 weeks
Secondary outcomes (1)
1-Minute Walk Test
The 1-minute walk test assesses walking capacity on a 20-meter indoor track, recording the distance a participant covers in one minute while walking as fast as possible without running.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2024
- Study start28 Jun 2024
- Primary completion20 Aug 2024
- Study completion25 Aug 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 Spastic 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It will be randomized control trial in which random sampling technique will be used. Two groups of 6-12 age will be formed in which participants will randomly be divided. Group A will receive Functional Progressive Resistance Exercises and group B will receive conventional stretching and strengthening exercises
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kashaf Naeem, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06407869
- Sponsor's protocol ID
- REC/RCR&AHS/23/0778
- Status last verified
- Oct 2024
- First submitted
- 6 May 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hanssen B, Peeters N, De Beukelaer N, Vannerom A, Peeters L, Molenaers G, Van Campenhout A, Deschepper E, Van den Broeck C, Desloovere K. Progressive resistance training for children with cerebral palsy: A randomized controlled trial evaluating the effects on muscle strength and morphology. Front Physiol. 2022 Oct 4;13:911162. doi: 10.3389/fphys.2022.911162. eCollection 2022.
PubMed 36267577
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Functional Progressive Strength Training on Gait Parameters and Walking Capacity in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06407869
- Acronym / sponsor ID
- REC/RCR&AHS/23/0778
- Conditions
- Spastic Cerebral Palsy
- Keywords
- Spastic CP, Functional Progressive Strength Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 25 Aug 2024 (actual)
- First posted
- 9 May 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.
This study focuses on the effects of Functional Progressive Strength Training (FPST) on children with spastic cerebral palsy, a condition characterized by increased muscle tone that affects movement. Spastic cerebral palsy is one type of cerebral palsy, with others including dyskinetic, which involves involuntary movements, and ataxic, which affects coordination. FPST differs from traditional strength training by incorporating exercises that replicate everyday activities to integrate strength use in daily movements. The study uses an experimental design with participants aged 6-12 years, recruited from specialized centers. They are randomly assigned to either a treatment group receiving FPST or a control group receiving standard care. The study aims to measure improvements in gait and mobility, assessed through various tools like step and stride length, cadence, and gait speed, alongside caregiver reports and direct observations. Statistical analyses will determine the effectiveness of FPST in enhancing motor function and walking capacity in these children.
Detailed description
In the outlined study, participants who fit the necessary inclusion and exclusion criteria are asked to provide written informed consent before taking part. The randomization process involves each participant drawing a number from a box: those who draw number one are placed in Group A (experimental group), while those drawing number two are placed in Group B (control group).
Group A undergoes a specialized treatment approach called Functional Progressive Resistance Exercise (FPRE), in addition to receiving conventional treatment. The FPRE regimen starts with a three-minute warm-up that includes range of motion mobilization and stretching exercises. This is followed by a series of resistance exercises, such as sit-to-stand activities, which increase in intensity over a six-week period, targeting specific percentages of body weight. The participants then engage in half-kneeling, standing up, and side-step-up exercises for 20 minutes each, with rest intervals. The session concludes with a two-minute cooldown. The protocol is designed to gradually increase the load carried by the participants, scaling up to five times, then 10 times, and eventually 15 times the initial weight, with a minimum of one minute of rest between sets. The exercises are calibrated through trial and error to find the maximum load that can be lifted for the defined number of repetitions and sets.
Group B participants receive conventional physical therapy aimed at maintaining muscle flexibility and improving motor function. Their routine includes an hour-long session three times a week, consisting of stretching exercises focused on muscles prone to tightness, such as the Achilles tendons, hamstrings, hip flexors, and adductors. Strength training targets specific muscle groups including hip flexors, knee extensors, and ankle dorsiflexors. The gait training in Group B starts in a controlled environment, such as walking between parallel bars, and progresses to more complex tasks like walking unassisted in open spaces, navigating different floor surfaces, and moving through obstacle-laden paths.
Both groups are reassessed after 12 weeks to evaluate the impact of their respective interventions on gait parameters and walking capacity, using a combination of direct observation, caregiver reports, and standardized assessment tools. The study aims to ascertain the relative efficacy of these two approaches in enhancing mobility and quality of life for children with spastic cerebral palsy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- It will be randomized control trial in which random sampling technique will be used. Two groups of 6-12 age will be formed in which participants will randomly be divided. Group A will receive Functional Progressive Resistance Exercises and group B will receive conventional stretching and strengthening exercises
| Arm | Type | Receives |
|---|---|---|
| Functional Progressive Strength Training | Experimental | Other: Functional Progressive Strength Traininggroup of 20 children with spastic cerebral palsy on which FPST techniques including 3 or 4 PRT sessions per week for 12 weekswill be applied. |
| Control | Other | Other: Controlgroup of 20 children with spastic cerebral palsy on which conventional physical therapy techniques will be applied |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 6 to 12 years
- Children had to be able to understand and follow instructions
- Diplegic CP
- GMFSC I, II, III
Key exclusion criteria (3 listed)
- Treatment with botulinum toxin A in lower limb.
- Rhizotomy done 6 months before the study.
- Children with unstable seizures will be excluded.
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 Progressive Strength TrainingThe Functional Progressive Resistance Exercise (FPRE) protocol is designed to improve functional strength through structured workouts. It begins with a 3-minute warmup involving stretching and range of motion exercises, followed by progressively intense sit-to-stand exercises over six weeks. Participants also perform half-kneeling, standing up, and side-step-up exercises, with 20 minutes of total activity and rest intervals. The session ends with a 2-minute cooldown. Weights are gradually increased up to 15 times the initial load, with a minimum of one-minute rest between sets. The regimen is tailored through trial and error to find the maximum load participants can effectively manage. | Other | Functional Progressive Strength Training |
| Controlconventional physical therapy techniques will be applied | Other | Control |
Primary outcome
Gait Parameters
Time frame: 12 weeks
To assess gait parameters in a study, four tools are utilized: step length, measuring the distance between alternating heel strikes; stride length, measuring the distance between two heel strikes of the same extremity; cadence, counting the number of steps taken; and gait speed, timing the duration to cover a 5-meter distance with a stopwatch.
1 secondary outcome
1-Minute Walk Test
Time frame: 12 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 28 Oct 2024.
- Background: PubMed 36267577Hanssen B, Peeters N, De Beukelaer N, Vannerom A, Peeters L, Molenaers G, Van Campenhout A, Deschepper E, Van den Broeck C, Desloovere K. Progressive resistance training for children with cerebral palsy: A randomized controlled trial evaluating the effects on muscle strength and morphology. Front Physiol. 2022 Oct 4;13:911162. doi: 10.3389/fphys.2022.911162. eCollection 2022.
- 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.
Kashaf Naeem, 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 Functional Progressive Strength Training in people with Spastic 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 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 28 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?
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?
Gait Parameters (time frame: 12 weeks). 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 NCT06407869, 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 28 Oct 2024.