Diplegic Cerebral Palsy With SpasticityNCT05500924
Effects of Ankle Mobilization on Body Structure, Function, Activities and Participation of Children With Cerebral Palsy
A study testing Intervention group in people with Diplegic Cerebral Palsy With Spasticity, run by Eastern Mediterranean University at 1 site in Palestinian Territories.
Trial summary
Cerebral palsy is the most common motor disability of childhood (Suvanand et al 1997). By definition CP is a static encephalopathy, but the musculoskeletal pathology is a major concern . Chronic neurologic impairment affects the development of bones and muscles. Read more about this study
- Who is it for?
- Ages 4 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Diplegic Cerebral Palsy With Spasticity
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 30 Jul 2022to 10 Jan 2023
- 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 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Spastic Diplegic CP
- healthy bones appropriate for mobilisation
- ages between 4-14
- GMFCS I, II
- Ashworth scale 2-3 (For Gastrocnemius Muscle)
- Good cognitive ability to understand the orders in the tests
- CP children who continued to take regular physiotherapy sessions
Who cannot join
- Recent correcting orthopaedic surgeries until 6 months before recruitment
- Children received or intending to receive Botox within an interval of 3 months
- Children who have full Ankle dorsal flexion.
- fixed contracture
Trial locations and contacts
1 site in 1 country.
Palestinian Territories1 site
Palestine Ahliya university
Bethlehem, p158
About this study
Official title: The Effects of Ankle Mulligan Mobilization on Range of Motion, Balance, Functional Performance and Quality of Life of Children With Diplegic Spastic Cerebral Palsy
Cerebral palsy is the most common motor disability of childhood (Suvanand et al 1997). By definition CP is a static encephalopathy, but the musculoskeletal pathology is a major concern . Chronic neurologic impairment affects the development of bones and muscles. In spastic hemiplegia, the affected side demonstrates muscle atrophy and limb shortening, compared to the unaffected side. Thus, CP is a neuromusculoskeletal disorder . Musculoskeletal conditions of people with CP can develop or worsen across the lifespan as a consequence of the primary neuromotor impairments which will affect their physical activity and participation. In fact these complications can lead to lose the ability of walking in ambulatory children up to 30% . (Peterson 2015) Physical inactivity among regularly growing paediatric community has become a general health load.
Neurological interventions are well documented, However, there is a gap of information and evidence documenting the orthopaedic intervention effect on orthopaedic secondary complications in CP. Even though the neurological pathology isn't progressive , the orthopaedic complication itself is progressive and affect the ability of the CP children to progress, and in so many cases they lose their functional achievements when their functional status can't meet their growth requirements any more, due to the neurological dysfunction and progressive secondary complications, that makes walking less efficient , less effective, and increased fatigue levels in gait. (Tosi et al. 2009).
Little is known about the practice of Brian Mulligan's mobilization with movement (MWM) in CP patients in early ages, for the secondary complication of the ankle hypomobility and ROM. This study will be conducted to discover the immediate effect of MWM on the ankle to improve the range and mobility of ankle as a musculoskeletal (dysfunction) for the function of gait.
Read the detailed description
Cerebral palsy is the most common motor disability of childhood (Suvanand et al 1997). By definition CP is a static encephalopathy, but the musculoskeletal pathology is a major concern . Chronic neurologic impairment affects the development of bones and muscles. In spastic hemiplegia, the affected side demonstrates muscle atrophy and limb shortening, compared to the unaffected side. Thus, CP is a neuromusculoskeletal disorder . Musculoskeletal conditions of people with CP can develop or worsen across the lifespan as a consequence of the primary neuromotor impairments which will affect their physical activity and participation. In fact these complications can lead to lose the ability of walking in ambulatory children up to 30% . (Peterson 2015) Physical inactivity among regularly growing paediatric community has become a general health load.
Neurological interventions are well documented, However, there is a gap of information and evidence documenting the orthopaedic intervention effect on orthopaedic secondary complications in CP. Even though the neurological pathology isn't progressive , the orthopaedic complication itself is progressive and affect the ability of the CP children to progress, and in so many cases they lose their functional achievements when their functional status can't meet their growth requirements any more, due to the neurological dysfunction and progressive secondary complications, that makes walking less efficient , less effective, and increased fatigue levels in gait. (Tosi et al. 2009).
Little is known about the practice of Brian Mulligan's mobilization with movement (MWM) in CP patients in early ages, for the secondary complication of the ankle hypomobility and ROM. This study will be conducted to discover the immediate effect of MWM on the ankle to improve the range and mobility of ankle as a musculoskeletal (dysfunction) for the function of gait.
Research questions What is the effect of Ankle MWM in functional activities on gait function ? What is the effect of Ankle MWM in functional activities on balance function ? What is the effect of Ankle MWM in functional activities on quality of life? What is the effect of Ankle MWM in functional activities on fatigue?
Research hypothesis Ankle MWM in functional activities improves gait function? Ankle MWM in functional activities improve balance? Ankle MWM in functional activities improves quality of life? Ankle MWM in functional activities increase happiness? Research objectives To investigate the effect of Ankle MWM in functional activities on gait function? To study the effect of Ankle MWM in functional activities on balance function? To highlight the effect of Ankle MWM in functional activities on quality of life? To study the effect of Ankle MWM in functional activities on happiness?
- Conditions
- Diplegic Cerebral Palsy With Spasticity
- Being tested
- Intervention group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
5 sets of functional activities each will be repeated for 3 times , while the therapist is performing mulligan mobilization techniques Sit to stand Squat Stand to sit Stairs stepping Bridging
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 5 sets of functional activities each will be repeated for 3 times , while the therapist is performing mulligan mobilization techniques Sit to stand Squat Stand to sit Stairs stepping Bridging Receives: Other: Intervention group |
| Control group | Experimental | 5 sets of functional activities each will be repeated for 3 times: Sit to stand Squat Stand to sit Stairs stepping Bridging Receives: Other: Intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Ankle Range of Motion
ROM of Ankle Dorsiflexion passively and actively will be done using goniometer to assess any changes.
Measured: Baseline and post 4 weeks assessment
Change in the Six minutes walking test: The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
For measuring the changes in walking activities.The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Measured: Baseline and post 4 weeks assessment
Change inTime up and go (TUG) test: The TUG test is a reliable and responsive measure of balance and mobility for children with CP
For assessing the change in Balance and mobility
Measured: Baseline and post 4 weeks assessment
Change in the Pediatric Quality of Life: it is measured by measure by CP-specific questionnaire. We will use The Arabic-CP-QOL-questionnaire
To assess the change in the quality of life and happiness of the children
Measured: Baseline and post 4 weeks assessment
Change in the Gross Motor Function Measure (GMFM) scale which is designed to measure changes in gross motor function over time or with intervention in children with cerebral palsy.
To assess the changes in the Functional performance in thegross motor function of Cerebral Palsy children
Measured: Baseline and post 4 weeks assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study start30 Jul 2022
- Primary completion22 Dec 2022
- Study completion10 Jan 2023
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 Diplegic Cerebral Palsy With SpasticityStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Mediterranean University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zehra G. Topco, PhD, Study director, Eastern Medeterranean University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05500924
- Sponsor's protocol ID
- ETK00-2022-0160
- Status last verified
- Dec 2022
- First submitted
- 4 Aug 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ragheb Abushameh RS, Topcu ZG, Tunal AN, Amro A, Arab AA. The effects of ankle mulligan mobilisation in children with cerebral palsy: A randomized single blind control study. J Pak Med Assoc. 2024 Jul;74(7):1219-1223. doi: 10.47391/JPMA.10328.
PubMed 39028043
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ankle Mulligan Mobilization on Range of Motion, Balance, Functional Performance and Quality of Life of Children With Diplegic Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05500924
- Acronym / sponsor ID
- ETK00-2022-0160
- Conditions
- Diplegic Cerebral Palsy With Spasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Eastern Mediterranean UniversityUniversity, hospital or other
- Study start
- 30 Jul 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 15 Aug 2022 (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 the most common motor disability of childhood (Suvanand et al 1997). By definition CP is a static encephalopathy, but the musculoskeletal pathology is a major concern . Chronic neurologic impairment affects the development of bones and muscles. In spastic hemiplegia, the affected side demonstrates muscle atrophy and limb shortening, compared to the unaffected side. Thus, CP is a neuromusculoskeletal disorder . Musculoskeletal conditions of people with CP can develop or worsen across the lifespan as a consequence of the primary neuromotor impairments which will affect their physical activity and participation. In fact these complications can lead to lose the ability of walking in ambulatory children up to 30% . (Peterson 2015) Physical inactivity among regularly growing paediatric community has become a general health load.
Neurological interventions are well documented, However, there is a gap of information and evidence documenting the orthopaedic intervention effect on orthopaedic secondary complications in CP. Even though the neurological pathology isn't progressive , the orthopaedic complication itself is progressive and affect the ability of the CP children to progress, and in so many cases they lose their functional achievements when their functional status can't meet their growth requirements any more, due to the neurological dysfunction and progressive secondary complications, that makes walking less efficient , less effective, and increased fatigue levels in gait. (Tosi et al. 2009).
Little is known about the practice of Brian Mulligan's mobilization with movement (MWM) in CP patients in early ages, for the secondary complication of the ankle hypomobility and ROM. This study will be conducted to discover the immediate effect of MWM on the ankle to improve the range and mobility of ankle as a musculoskeletal (dysfunction) for the function of gait.
Detailed description
Cerebral palsy is the most common motor disability of childhood (Suvanand et al 1997). By definition CP is a static encephalopathy, but the musculoskeletal pathology is a major concern . Chronic neurologic impairment affects the development of bones and muscles. In spastic hemiplegia, the affected side demonstrates muscle atrophy and limb shortening, compared to the unaffected side. Thus, CP is a neuromusculoskeletal disorder . Musculoskeletal conditions of people with CP can develop or worsen across the lifespan as a consequence of the primary neuromotor impairments which will affect their physical activity and participation. In fact these complications can lead to lose the ability of walking in ambulatory children up to 30% . (Peterson 2015) Physical inactivity among regularly growing paediatric community has become a general health load.
Neurological interventions are well documented, However, there is a gap of information and evidence documenting the orthopaedic intervention effect on orthopaedic secondary complications in CP. Even though the neurological pathology isn't progressive , the orthopaedic complication itself is progressive and affect the ability of the CP children to progress, and in so many cases they lose their functional achievements when their functional status can't meet their growth requirements any more, due to the neurological dysfunction and progressive secondary complications, that makes walking less efficient , less effective, and increased fatigue levels in gait. (Tosi et al. 2009).
Little is known about the practice of Brian Mulligan's mobilization with movement (MWM) in CP patients in early ages, for the secondary complication of the ankle hypomobility and ROM. This study will be conducted to discover the immediate effect of MWM on the ankle to improve the range and mobility of ankle as a musculoskeletal (dysfunction) for the function of gait.
Research questions What is the effect of Ankle MWM in functional activities on gait function ? What is the effect of Ankle MWM in functional activities on balance function ? What is the effect of Ankle MWM in functional activities on quality of life? What is the effect of Ankle MWM in functional activities on fatigue?
Research hypothesis Ankle MWM in functional activities improves gait function? Ankle MWM in functional activities improve balance? Ankle MWM in functional activities improves quality of life? Ankle MWM in functional activities increase happiness? Research objectives To investigate the effect of Ankle MWM in functional activities on gait function? To study the effect of Ankle MWM in functional activities on balance function? To highlight the effect of Ankle MWM in functional activities on quality of life? To study the effect of Ankle MWM in functional activities on happiness?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention group5 sets of functional activities each will be repeated for 3 times , while the therapist is performing mulligan mobilization techniques Sit to stand Squat Stand to sit Stairs stepping Bridging |
| Control group | Experimental | Other: Intervention group5 sets of functional activities each will be repeated for 3 times: Sit to stand Squat Stand to sit Stairs stepping Bridging |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Spastic Diplegic CP
- healthy bones appropriate for mobilisation
- ages between 4-14
- GMFCS I, II
- Ashworth scale 2-3 (For Gastrocnemius Muscle)
Key exclusion criteria (4 listed)
- Recent correcting orthopaedic surgeries until 6 months before recruitment
- Children received or intending to receive Botox within an interval of 3 months
- Children who have full Ankle dorsal flexion.
- fixed contracture
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 |
|---|---|---|
| Intervention group5 sets of functional activities each will be repeated for 3 times , while the therapist is performing mulligan mobilization techniques Sit to stand Squat Stand to sit Stairs stepping Bridging | Other | Control group, Intervention group |
Primary outcome
Change of Ankle Range of Motion
Time frame: Baseline and post 4 weeks assessment
ROM of Ankle Dorsiflexion passively and actively will be done using goniometer to assess any changes.
Change in the Six minutes walking test: The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Time frame: Baseline and post 4 weeks assessment
For measuring the changes in walking activities.The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface
Change inTime up and go (TUG) test: The TUG test is a reliable and responsive measure of balance and mobility for children with CP
Time frame: Baseline and post 4 weeks assessment
For assessing the change in Balance and mobility
Change in the Pediatric Quality of Life: it is measured by measure by CP-specific questionnaire. We will use The Arabic-CP-QOL-questionnaire
Time frame: Baseline and post 4 weeks assessment
To assess the change in the quality of life and happiness of the children
Change in the Gross Motor Function Measure (GMFM) scale which is designed to measure changes in gross motor function over time or with intervention in children with cerebral palsy.
Time frame: Baseline and post 4 weeks assessment
To assess the changes in the Functional performance in thegross motor function of Cerebral Palsy children
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 12 Jan 2023.
- Derived from this study: PubMed 39028043Ragheb Abushameh RS, Topcu ZG, Tunal AN, Amro A, Arab AA. The effects of ankle mulligan mobilisation in children with cerebral palsy: A randomized single blind control study. J Pak Med Assoc. 2024 Jul;74(7):1219-1223. doi: 10.47391/JPMA.10328.
- 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.
Zehra G. Topco, PhD study director
Eastern Medeterranean 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 Intervention group in people with Diplegic Cerebral Palsy With Spasticity, run by Eastern Mediterranean University at 1 site in Palestinian Territories.
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 7 inclusion and 4 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 12 Jan 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 Palestinian Territories. 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?
Change of Ankle Range of Motion (time frame: Baseline and post 4 weeks assessment). The study lists 5 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 NCT05500924, 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 12 Jan 2023.