Spastic Cerebral Palsy (sCP)NCT06598657
Talocrural Mobilization With Movement in Spastic Cerebral Palsy
A study testing Mobilization with Movement MWM and Conventional Treatment in people with Spastic Cerebral Palsy (sCP), run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial is to find the effect of Mulligan's Mobilization with Movement of Talocrural joint in Cerebral Palsy Patients having spasticity on improving Ankle Range of Motion, improving balance and its effect on Gait speed. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- What is being tested?
- Mobilization with Movement MWM and Conventional Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Oct 2024to 25 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both genders
- Age group 8-18 years
- Diagnosis of spastic Cerebral Palsy
- CP to follow verbal directions
- Modified Ashworth Scale score of '1' or '1+'
- Function classification system (GMFCS) level I or II ability to walk
- 10 m or more independently
Who cannot join
- visual, hearing disorders
- verbal and cognitive disorders (unable to comprehend commands)
- recent lower extremity surgery
- botulinum toxin injection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
PAF School for Persons With special Needs PNS, Islamabad
Islamabad, Punjab Province, 46600
KINZA ANWAR, MS-OMPT, +92-3239735427, kinza.anwar@riphah.edu.pk
MAIMOONA MUBARIK, MS-OMPT*
About this study
Official title: Effects of Talocrural Joint Mobilization With Movement in Spastic Cerebral Palsy Patients
The aim of this randomized controlled trial is to find the effect of Mulligan's Mobilization with Movement of Talocrural joint in Cerebral Palsy Patients having spasticity on improving Ankle Range of Motion, improving balance and its effect on Gait speed.
Read the detailed description
Cerebral palsy is a neurodevelopmental disorder involving abnormalities in muscle tone and motor function due to damaged cerebral tissue in development. It is a nonprogressive upper motor neuron lesion characterized by abnormal tone, posture, balance and movement and clinically classified based on the predominant motor syndrome. In spastic CP, there is significant weakness that contributes to abnormal posture and movement. This is also accompanied by decreased muscle endurance and loss of selective motor control (SMC). Spastic diplegia is a very common form of CP, with a wide range of ambulatory outcomes, and is most frequently accompanied by ankle spasticity. Abnormalities, such as excessive plantar flexion of the ankle, leads to individuals with CP have in both static and dynamic balance.
Joint mobilization has not only the mechanical effect of disrupting the contracture by direct movement of the joint area, but also stimulates mechanoreceptor activation when stretching occurs in the capsule and ankle ligaments.
The Mulligan Mobilization with movement (MWM) is a physical therapy technique that combines joint mobilization techniques with active movement. It aims to improve joint range of motion, reduce stiffness, and enhance functional mobility, is expected to produce an instantaneous improvement in the patient's abilities by simultaneous applying of pain-free accessory glides.
This study will contribute in describing long lasting effects of Mobilization With Movement, with multiple assessments, on ankle range of motion, balance, and gait speed, and to check whether the amount of regaining is similar between patients undergoing MWM with conventional therapy and those with conventional therapy alone
- Conditions
- Spastic Cerebral Palsy (sCP)
- Being tested
- Mobilization with Movement MWM, Conventional Treatment
- Keywords
- Talocrural joint, Mobilization with Movement, Spasticity cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobilization with Movement MWMOther
Mobilization with Movement MWM of Talocrural joint in non-weight bearing position to improve Dorsiflexion Range of Motion (3 sets of 6 repetitions were applied, with a 1-minute break between sets/3 times a week) and conventional therapy which includes stretching, strengthening, balance training exercise.
Conventional TreatmentOther
- Stretches of Hamstrings, Gastrocnemius, Soleus and hip adductors with duration of 20 sec hold/ 5 reps and Frequency: 3 times/week. Stretches will be performed passively
- Strengthening exercises of Quadriceps and abdominal muscles three times a week.
- Static balance exercises including single leg balance, tandem stance, weight shifting with Duration: 10 sec hold/ 5 reps Frequency: 3 times/week
| Study group | Role | What they receive |
|---|---|---|
| Mobilization with Movement MWM of Talocrural joint + Conventional PT | Active comparator | Not described Receives: Other: Mobilization with Movement MWM |
| Conventional PT | Other | Not described Receives: Other: Conventional Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Up and Go
In the TUG test, a child begins in a seated position on a chair or other designated surface. They are instructed to stand up, walk a specific distance (usually three meters or ten feet), turn around, and return to the seated position. The time taken to complete the task is recorded. Evaluation is made by comparing pre and post-intervention. To assess mobility of patient.
Measured: 4 weeks
10 m WALK TEST
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility and gait. Stopwatch is used and the total time taken to ambulate 6 meters is recorded. Timing starts when the toes pass the 2-meter mark. Timing stops when the toes pass the 8-meter mark. The 6m is then divided by the total time taken (in seconds) to completed. The total time is recorded in m/s
Measured: 4 weeks
Goniometer
It is an instrument that measures the available range of motion at a joint.
Measured: 4 weeks
Modified Ashworth Scale (MAS)
Modified Ashworth Scale (MAS) is used to assess spasticity. Different grades from 0 to 4 are used to access increased tone and spasticity. With 0 referring to "No increase in tone" and 4 refers to "Affected part rigid in flexion/extension" The measurements are recorded at baseline, during treatment and after treatment protocol.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start2 Oct 2024
- Primary completion25 Sep 2025 (estimated)
- Study completion25 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Cerebral Palsy (sCP)Studies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- KINZA ANWAR, MS-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598657
- Sponsor's protocol ID
- REC/01877 Maimoona Mubarik
- Status last verified
- Feb 2025
- First submitted
- 12 Sep 2024
- Last updated
- 21 Feb 2025
- 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 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Talocrural Joint Mobilization With Movement in Spastic Cerebral Palsy Patients
- ClinicalTrials.gov ID
- NCT06598657
- Acronym / sponsor ID
- REC/01877 Maimoona Mubarik
- Conditions
- Spastic Cerebral Palsy (sCP)
- Keywords
- Talocrural joint, Mobilization with Movement, Spasticity cerebral palsy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 25 Sep 2025 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 19 Sep 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.
The aim of this randomized controlled trial is to find the effect of Mulligan's Mobilization with Movement of Talocrural joint in Cerebral Palsy Patients having spasticity on improving Ankle Range of Motion, improving balance and its effect on Gait speed.
Detailed description
Cerebral palsy is a neurodevelopmental disorder involving abnormalities in muscle tone and motor function due to damaged cerebral tissue in development. It is a nonprogressive upper motor neuron lesion characterized by abnormal tone, posture, balance and movement and clinically classified based on the predominant motor syndrome. In spastic CP, there is significant weakness that contributes to abnormal posture and movement. This is also accompanied by decreased muscle endurance and loss of selective motor control (SMC). Spastic diplegia is a very common form of CP, with a wide range of ambulatory outcomes, and is most frequently accompanied by ankle spasticity. Abnormalities, such as excessive plantar flexion of the ankle, leads to individuals with CP have in both static and dynamic balance.
Joint mobilization has not only the mechanical effect of disrupting the contracture by direct movement of the joint area, but also stimulates mechanoreceptor activation when stretching occurs in the capsule and ankle ligaments.
The Mulligan Mobilization with movement (MWM) is a physical therapy technique that combines joint mobilization techniques with active movement. It aims to improve joint range of motion, reduce stiffness, and enhance functional mobility, is expected to produce an instantaneous improvement in the patient's abilities by simultaneous applying of pain-free accessory glides.
This study will contribute in describing long lasting effects of Mobilization With Movement, with multiple assessments, on ankle range of motion, balance, and gait speed, and to check whether the amount of regaining is similar between patients undergoing MWM with conventional therapy and those with conventional therapy alone
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilization with Movement MWM of Talocrural joint + Conventional PT | Active comparator | Other: Mobilization with Movement MWM |
| Conventional PT | Other | Other: Conventional Treatment |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Both genders
- Age group 8-18 years
- Diagnosis of spastic Cerebral Palsy
- CP to follow verbal directions
- Modified Ashworth Scale score of '1' or '1+'
Key exclusion criteria (4 listed)
- visual, hearing disorders
- verbal and cognitive disorders (unable to comprehend commands)
- recent lower extremity surgery
- botulinum toxin injection
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 |
|---|---|---|
| Mobilization with Movement MWMMobilization with Movement MWM of Talocrural joint in non-weight bearing position to improve Dorsiflexion Range of Motion (3 sets of 6 repetitions were applied, with a 1-minute break between sets/3 times a week) and conventional therapy which includes stretching, strengthening, balance training exercise. | Other | Mobilization with Movement MWM of Talocrural joint + Conventional PT |
| Conventional Treatment* Stretches of Hamstrings, Gastrocnemius, Soleus and hip adductors with duration of 20 sec hold/ 5 reps and Frequency: 3 times/week. Stretches will be performed passively * Strengthening exercises of Quadriceps and abdominal muscles three times a week. * Static balance exercises including single leg balance, tandem stance, weight shifting with Duration: 10 sec hold/ 5 reps Frequency: 3 times/week | Other | Conventional PT |
Primary outcome
Time Up and Go
Time frame: 4 weeks
In the TUG test, a child begins in a seated position on a chair or other designated surface. They are instructed to stand up, walk a specific distance (usually three meters or ten feet), turn around, and return to the seated position. The time taken to complete the task is recorded. Evaluation is made by comparing pre and post-intervention. To assess mobility of patient.
10 m WALK TEST
Time frame: 4 weeks
The 10 Meter Walk Test is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility and gait. Stopwatch is used and the total time taken to ambulate 6 meters is recorded. Timing starts when the toes pass the 2-meter mark. Timing stops when the toes pass the 8-meter mark. The 6m is then divided by the total time taken (in seconds) to completed. The total time is recorded in m/s
Goniometer
Time frame: 4 weeks
It is an instrument that measures the available range of motion at a joint.
Modified Ashworth Scale (MAS)
Time frame: 4 weeks
Modified Ashworth Scale (MAS) is used to assess spasticity. Different grades from 0 to 4 are used to access increased tone and spasticity. With 0 referring to "No increase in tone" and 4 refers to "Affected part rigid in flexion/extension" The measurements are recorded at baseline, during treatment and after treatment protocol.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Spastic Cerebral Palsy (sCP)
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Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm
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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.
KINZA ANWAR, MS-OMPT 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 Mobilization with Movement MWM and Conventional Treatment in people with Spastic Cerebral Palsy (sCP), 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 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: looking for participants now, as of the sponsor's last update on 21 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact KINZA ANWAR, MS-OMPT (+92-3239735427, kinza.anwar@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time Up and Go (time frame: 4 weeks). The study lists 4 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 21 Feb 2025.