Cerebral PalsyNCT06460714
Effects of Shockwave Therapy on Crouched Gait Due to Hamstring Flexibility in Cerebral Palsy Children
A study testing Shock wave therapy, stretching and orthosis and Stretching, strengthening and orthosis in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Randomized controlled trial will be conducted on thirty-two cerebral palsy children in Punjab Special School. Spastic Diplegic CP children with GMFCs level III, IV, V with age range of 6 to 12. These children have limited range of hamstring muscles. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Shock wave therapy, stretching and orthosis and Stretching, strengthening and orthosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2024to 10 Jul 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
- Children with GMFCS level I, II \& III.
- Passive range of motion of knee extension is limited to 20 degree with hip 90 degree.
- Age between 6 to 12 years.
Who cannot join
- Children with epileptic history
- Previous muscular lengthening technique applied
- Previous history of botox injection used.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Shockwave Therapy on Crouched Gait and Hamstring Flexibility in Children With Diplegic Cerebral Palsy.
Randomized controlled trial will be conducted on thirty-two cerebral palsy children in Punjab Special School. Spastic Diplegic CP children with GMFCs level III, IV, V with age range of 6 to 12. These children have limited range of hamstring muscles. Assessment will be measured Pre and Post treatment by goniometer of crouched gait in standing and lying on couch. Crouched gait will be measured by Knee flexion in standing and lying. To measure hamstring flexibility ROM of knee extension is measured with 90 flexion at hip joint. Spasticity in this study will be assessed by GMFM-88 and modified Ashworth scale.
Read the detailed description
Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days, five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.
In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.
- Conditions
- Cerebral Palsy
- Being tested
- Shock wave therapy, stretching and orthosis, Stretching, strengthening and orthosis
- Keywords
- Cerebral Palsy, Shock wave, Hamstring flexibility, Crouched gait
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock wave therapy, stretching and orthosisOther
Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days in a week provided five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.
Stretching, strengthening and orthosisOther
In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.
| Study group | Role | What they receive |
|---|---|---|
| Shock wave therapy, stretching and orthosis | Experimental | Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days in a week provided five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect. Receives: Other: Shock wave therapy, stretching and orthosis |
| Stretching, strengthening and orthosis | Active comparator | In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis. Receives: Other: Stretching, strengthening and orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashwarth Scale
The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to evaluate muscle tone and spasticity in individuals with neurological conditions such as spastic cerebral palsy. It is a reliable and valid method for grading muscle resistance during passive movement. interrater reliability of AS and MAS varied from moderate to good. ICC scores of AS were between 0.54 and 0.78 and MAS were between 0.61-0.87. Test-retest results of AS and MAS varied from poor to good. ICC values were between 0.31 and 0.82 for AS and between 0.36 and 0.83 for MAS
Measured: 8 weeks
GMFM-88
The Gross Motor Function Measure-88 (GMFM-88) is widely used tool for assessing changes in gross motor function among children with cerebral palsy. It comprising 88 items across five domains. GMFM-A includes activities such as lying and rolling, GMFM-B includes sitting, Crawling and kneeling includes in GMFM-C, GMFM-D includes standing and walking, running and jumping includes in GMFM-E. The reliability of GMFM-88 is 0.75 to 1.0.
Measured: 8 weeks
Goniometer
A goniometer is a measurement tool commonly used in rehabilitation and physical therapy to assess the range of motion (ROM) of various joints in the body. It consists of a stationary arm and a movable arm with a protractor-like scale, allowing for precise measurement of joint angles. By aligning the stationary arm with the joint's axis and the movable arm with the body segment, the goniometer provides objective measurements of joint flexibility, mobility, and muscle strength. The goniometer provides valuable quantitative data that can guide treatment planning, monitor patient progress, and assess functional outcomes related to joint movement and mobility.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start5 Apr 2024
- Primary completion30 Jun 2024
- Study completion10 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Control trial in which non-probability convenient sampling will be used. Both group of spastic CP of age 6 to 12 will be randomly divided. Group A will receive shockwave, stretching and orthosis. Group B will receive stretching and orthosis.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Fahad Asif, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06460714
- Sponsor's protocol ID
- REC/RCR&AHS/23/0775
- Status last verified
- Jul 2024
- First submitted
- 11 Jun 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
PubMed 32053326Lowing K, Arredondo YC, Tedroff M, Tedroff K. Introduction of the gross motor function classification system in Venezuela--a model for knowledge dissemination. BMC Pediatr. 2015 Sep 4;15:111. doi: 10.1186/s12887-015-0433-5.
PubMed 26341265Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.
PubMed 28698802
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Shockwave Therapy on Crouched Gait and Hamstring Flexibility in Children With Diplegic Cerebral Palsy.
- ClinicalTrials.gov ID
- NCT06460714
- Acronym / sponsor ID
- REC/RCR&AHS/23/0775
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Shock wave, Hamstring flexibility, Crouched gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 14 Jun 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.
Randomized controlled trial will be conducted on thirty-two cerebral palsy children in Punjab Special School. Spastic Diplegic CP children with GMFCs level III, IV, V with age range of 6 to 12. These children have limited range of hamstring muscles. Assessment will be measured Pre and Post treatment by goniometer of crouched gait in standing and lying on couch. Crouched gait will be measured by Knee flexion in standing and lying. To measure hamstring flexibility ROM of knee extension is measured with 90 flexion at hip joint. Spasticity in this study will be assessed by GMFM-88 and modified Ashworth scale.
Detailed description
Shortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days, five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect.
In Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Control trial in which non-probability convenient sampling will be used. Both group of spastic CP of age 6 to 12 will be randomly divided. Group A will receive shockwave, stretching and orthosis. Group B will receive stretching and orthosis.
| Arm | Type | Receives |
|---|---|---|
| Shock wave therapy, stretching and orthosis | Experimental | Other: Shock wave therapy, stretching and orthosisShortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days in a week provided five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect. |
| Stretching, strengthening and orthosis | Active comparator | Other: Stretching, strengthening and orthosisIn Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with GMFCS level I, II \& III.
- Passive range of motion of knee extension is limited to 20 degree with hip 90 degree.
- Age between 6 to 12 years.
Key exclusion criteria (3 listed)
- Children with epileptic history
- Previous muscular lengthening technique applied
- Previous history of botox injection used.
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 |
|---|---|---|
| Shock wave therapy, stretching and orthosisShortwave therapy, stretching and orthotics will be provided to Group A. Shock wave session will be provided for 20 minutes thrice a week. Five days in a week provided five minutes with 30 seconds sustained stretch will be provided and than orthotics will be used to obtained the sustained effect. | Other | Shock wave therapy, stretching and orthosis |
| Stretching, strengthening and orthosisIn Group B spastic diplegic children just given stretching with strengthening and orthotics. We provide sustained 30 seconds stretch with 30 seconds rest for 5 minutes and followed with forty repetition of hip flexor and knee flexors and range will be maintained by applying orthosis. | Other | Stretching, strengthening and orthosis |
Primary outcome
Modified Ashwarth Scale
Time frame: 8 weeks
The Modified Ashworth Scale (MAS) is a commonly used clinical assessment tool to evaluate muscle tone and spasticity in individuals with neurological conditions such as spastic cerebral palsy. It is a reliable and valid method for grading muscle resistance during passive movement. interrater reliability of AS and MAS varied from moderate to good. ICC scores of AS were between 0.54 and 0.78 and MAS were between 0.61-0.87. Test-retest results of AS and MAS varied from poor to good. ICC values were between 0.31 and 0.82 for AS and between 0.36 and 0.83 for MAS
GMFM-88
Time frame: 8 weeks
The Gross Motor Function Measure-88 (GMFM-88) is widely used tool for assessing changes in gross motor function among children with cerebral palsy. It comprising 88 items across five domains. GMFM-A includes activities such as lying and rolling, GMFM-B includes sitting, Crawling and kneeling includes in GMFM-C, GMFM-D includes standing and walking, running and jumping includes in GMFM-E. The reliability of GMFM-88 is 0.75 to 1.0.
Goniometer
Time frame: 8 weeks
A goniometer is a measurement tool commonly used in rehabilitation and physical therapy to assess the range of motion (ROM) of various joints in the body. It consists of a stationary arm and a movable arm with a protractor-like scale, allowing for precise measurement of joint angles. By aligning the stationary arm with the joint's axis and the movable arm with the body segment, the goniometer provides objective measurements of joint flexibility, mobility, and muscle strength. The goniometer provides valuable quantitative data that can guide treatment planning, monitor patient progress, and assess functional outcomes related to joint movement and mobility.
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 Jul 2024.
- Background: PubMed 32053326Vitrikas K, Dalton H, Breish D. Cerebral Palsy: An Overview. Am Fam Physician. 2020 Feb 15;101(4):213-220.
- Background: PubMed 26341265Lowing K, Arredondo YC, Tedroff M, Tedroff K. Introduction of the gross motor function classification system in Venezuela--a model for knowledge dissemination. BMC Pediatr. 2015 Sep 4;15:111. doi: 10.1186/s12887-015-0433-5.
- Background: PubMed 28698802Armand S, Decoulon G, Bonnefoy-Mazure A. Gait analysis in children with cerebral palsy. EFORT Open Rev. 2016 Dec 22;1(12):448-460. doi: 10.1302/2058-5241.1.000052. eCollection 2016 Dec.
- 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.
Muhammad Fahad Asif, 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 Shock wave therapy, stretching and orthosis and Stretching, strengthening and orthosis 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 3 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 Jul 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?
Modified Ashwarth Scale (time frame: 8 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?
On the ClinicalTrials.gov record for NCT06460714, which also lists 3 linked publications.
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 Jul 2024.