Spastic Cerebral Palsy (sCP)NCT06673849
Rhythmic Stabilization Versus Ball Balancing
A study testing Rhythmic Stabilization and Ball Balancing in people with Spastic Cerebral Palsy (sCP), run by Riphah International University at 1 site in Pakistan.
Trial summary
Spastic Cerebral Palsy (CP) is the leading cause of upper motor neuron syndrome (UMN) in children. The primary factors contributing to motor behavior disorders in these children are impairments in motor control and muscle strength. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Spastic Cerebral Palsy (sCP)
- What is being tested?
- Rhythmic Stabilization and Ball Balancing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Sep 2024to 2 Jan 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Spastic diplegic CP children age 6 to 12 years,
- Each gender included
- Grade 1 of spasticity according to modified Ashworth scale (21)
- With normal I.Q. greater than 70 (assessed by psychologist),
- Can follow commands(
Who cannot join
- Children with any other neurological impairment
- Children with audio visual impairment
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
Riphah International University
Lahore, Punjab Province, 54700
Imran Amjad, PhD, 9233224390125, Imran.amjad@riphah.edu.pk
Muhammad Asif Javed, MS, 03224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Rhythmic Stabilization Versus Ball Balancing on Upper Extremity Function in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy (CP) is the leading cause of upper motor neuron syndrome (UMN) in children. The primary factors contributing to motor behavior disorders in these children are impairments in motor control and muscle strength. These impairments result in changes in muscle growth and hinder the development of motor skills, leading to reduced muscle force generation and decreased flexibility. Spastic cerebral palsy is the most prevalent type, affecting 77% of individuals with CP, and is caused by damage to the motor cortex and pyramidal tracts. The motor cortex is responsible for transmitting voluntary movement signals from the brain to the muscles. Characteristics of spastic cerebral palsy include stiff muscles (hypertonia), which can cause jerky and repetitive limb movements (spasticity). Additionally, individuals with CP often have difficulties in processing somatosensory and proprioceptive information. Proprioceptive training refers to interventions aimed at enhancing proprioceptive function to ultimately improve motor performance, a concept that has been explored in studies focused on sports injuries. In this study, we will utilize two proprioceptive exercises-rhythmic stabilization and ball balancing-to promote functional improvement in the upper extremities of children with spastic CP.
Read the detailed description
There will be two groups: Group A will consist of 16 patients undergoing rhythmic stabilization, while Group B will also have 16 patients participating in ball balancing activities. Data will be collected both before and after the intervention to determine the most effective approach. Data analysis will be conducted using SPSS version 23.00.
This study will be a randomized clinical trial, with data collected from the University of Lahore Teaching Hospital (ULTH) and the Pakistan Society for the Rehabilitation of the Disabled (PSRD) in Lahore. A total of 32 patients will participate, equally divided into two groups through random allocation. The inclusion criteria will consist of children aged 5-12 with spastic CP, encompassing both genders. Patients with any neurological conditions, other orthopedic issues, a history of spine surgery, severe systemic disorders, psychiatric disorders, or neuromuscular disorders will be excluded from the study.
- Conditions
- Spastic Cerebral Palsy (sCP)
- Being tested
- Rhythmic Stabilization, Ball Balancing
- Keywords
- Ball Balancing, Corticobulbar tracts, Corticospinal tracts, Epilepsy, Rhythmic Stabilization, Spastic CP
- Medical subject headings
- Cerebral Palsy, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic StabilizationOther
Rhythmic Stabilization Program for Children with Cerebral Palsy Objective: Enhance upper extremity strength and stability through rhythmic stabilization exercises.
Program Overview:
Duration: 30-minute sessions Frequency: Once per week for 6 weeks
Exercise Steps:
Positioning: The child positions their upper extremity within their available range of motion.
Isometric Contraction: The child holds an isometric contraction, maintaining the position without movement.
Therapist's Role: Apply resistance that is sufficient to elicit a reaction but not enough to disrupt the isometric contraction.
Progression: Gradually increase the duration of the isometric hold. Increase the amount of resistance applied. Decrease the contact area between the therapist's hands and the child's upper extremity to enhance stability challenges. Monitoring and Adjustments: Assess the child's ability to maintain the contraction and adapt the resistance and support as needed. Encourage the child's engagement.
Ball BalancingOther
Ball Balancing Program Objective: Improve balance and stability. Equipment: 48-inch gymnastic ball
Program Details:
- Duration: 6 weeks
- Frequency: As needed
Steps:
- Initial Balance:
- Eyes Open: Balance on hands for 10 seconds.
- Progression: Increase to 3-5 repetitions of 60 seconds.
- Eyes Closed: Repeat the above exercise with eyes closed.
- Variations:
- Both Hands on One Ball
- Each Hand on Separate Balls
- Weaker Arm on One Ball
- Body Positions: Progress through four body positions with eyes open, then closed.
- Correction: If the child misses a position, they open their eyes and reposition actively.
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic Stabilization group | Experimental | The CP child will positions his/her upper extremity anywhere in its available range of motion and holds an isometric contraction. The physiotherapist will provide enough resistance to cause the child to react, but not enough to break the isometric contraction. As the child progresses, length of time of rhythmic stabilization increases, the therapist's resistance increases, and amount of contact area between therapist's hands and child's upper extremity decreases. The exercise program consisted of 30-minute sessions per week for six weeks Receives: Other: Rhythmic Stabilization |
| Ball Balancing group | Experimental | Have the child balance on his/her hands on a 48-inch Gymnastic ball, first with eyes open, then closed. Progress from both hands on one large ball to each hand on separate balls and then to the weaker arm on one ball. Also, progress through the four body positions. With his/her eyes open, then closed. If he/she misses the position, he/she opens his/her eyes and actively moves to the desired position. Use a spotter, especially when doing this exercise for the first time or changing body positions, since the patient may fall off the Gymnastic ball. Start with one repetition of 10 seconds and progress to three to five repetitions of 60 seconds each and this will be done till 6 weeks Receives: Other: Ball Balancing |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUEST ( Quality of Upper Extremity Skills Test)
The Quality of Upper Extremity Skills Test (QUEST) is a reliable and valid tool that assesses hand function and movement patterns in children with cerebral palsy. It can be used with children aged 6 to 12 years (23). The test is conducted in a play environment and consists of 34 activity items. The test assesses four domains: Dissociated movements, Grasp, Protective extension. Reliability is 0.96 and validity is 0.84.
Measured: 6 weeks
SHUEE Scale
The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and Effects of Rhythmic Stabilization versus Ball Balancing on Spastic CP 3dynamic positional analysis and assesses the ability to perform grasp and release. The validity is 0.47 and reliability is 0.99
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 posted5 Nov 2024
- Study start25 Sep 2024
- Primary completion2 Dec 2024 (estimated)
- Study completion2 Jan 2025 (estimated)
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 Palsy (sCP)Studies 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
- Model description
- The study design will be a Randomized Clinical Trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will receive Rhythmic Stabilization exercises and Group B will receive Ball Balancing.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Masifah Kashif, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06673849
- Sponsor's protocol ID
- REC/RCR/AHS/24/MASIFAH
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01.
PubMed 32206590
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Rhythmic Stabilization Versus Ball Balancing on Upper Extremity Function in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06673849
- Acronym / sponsor ID
- REC/RCR/AHS/24/MASIFAH
- Conditions
- Spastic Cerebral Palsy (sCP)
- Keywords
- Ball Balancing, Corticobulbar tracts, Corticospinal tracts, Epilepsy, Rhythmic Stabilization, Spastic CP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Sep 2024 (actual)
- Primary completion
- 2 Dec 2024 (estimated)
- Study completion
- 2 Jan 2025 (estimated)
- First posted
- 5 Nov 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.
Spastic Cerebral Palsy (CP) is the leading cause of upper motor neuron syndrome (UMN) in children. The primary factors contributing to motor behavior disorders in these children are impairments in motor control and muscle strength. These impairments result in changes in muscle growth and hinder the development of motor skills, leading to reduced muscle force generation and decreased flexibility. Spastic cerebral palsy is the most prevalent type, affecting 77% of individuals with CP, and is caused by damage to the motor cortex and pyramidal tracts. The motor cortex is responsible for transmitting voluntary movement signals from the brain to the muscles. Characteristics of spastic cerebral palsy include stiff muscles (hypertonia), which can cause jerky and repetitive limb movements (spasticity). Additionally, individuals with CP often have difficulties in processing somatosensory and proprioceptive information. Proprioceptive training refers to interventions aimed at enhancing proprioceptive function to ultimately improve motor performance, a concept that has been explored in studies focused on sports injuries. In this study, we will utilize two proprioceptive exercises-rhythmic stabilization and ball balancing-to promote functional improvement in the upper extremities of children with spastic CP.
Detailed description
There will be two groups: Group A will consist of 16 patients undergoing rhythmic stabilization, while Group B will also have 16 patients participating in ball balancing activities. Data will be collected both before and after the intervention to determine the most effective approach. Data analysis will be conducted using SPSS version 23.00.
This study will be a randomized clinical trial, with data collected from the University of Lahore Teaching Hospital (ULTH) and the Pakistan Society for the Rehabilitation of the Disabled (PSRD) in Lahore. A total of 32 patients will participate, equally divided into two groups through random allocation. The inclusion criteria will consist of children aged 5-12 with spastic CP, encompassing both genders. Patients with any neurological conditions, other orthopedic issues, a history of spine surgery, severe systemic disorders, psychiatric disorders, or neuromuscular disorders will be excluded from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study design will be a Randomized Clinical Trial in which non probability convenient sampling will be used. Two groups of 6-12 age will be formed in which participants will be randomly divided. Group A will receive Rhythmic Stabilization exercises and Group B will receive Ball Balancing.
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Stabilization group | Experimental | Other: Rhythmic StabilizationThe CP child will positions his/her upper extremity anywhere in its available range of motion and holds an isometric contraction. The physiotherapist will provide enough resistance to cause the child to react, but not enough to break the isometric contraction. As the child progresses, length of time of rhythmic stabilization increases, the therapist's resistance increases, and amount of contact area between therapist's hands and child's upper extremity decreases. The exercise program consisted of 30-minute sessions per week for six weeks |
| Ball Balancing group | Experimental | Other: Ball BalancingHave the child balance on his/her hands on a 48-inch Gymnastic ball, first with eyes open, then closed. Progress from both hands on one large ball to each hand on separate balls and then to the weaker arm on one ball. Also, progress through the four body positions. With his/her eyes open, then closed. If he/she misses the position, he/she opens his/her eyes and actively moves to the desired position. Use a spotter, especially when doing this exercise for the first time or changing body positions, since the patient may fall off the Gymnastic ball. Start with one repetition of 10 seconds and progress to three to five repetitions of 60 seconds each and this will be done till 6 weeks |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Spastic diplegic CP children age 6 to 12 years,
- Each gender included
- Grade 1 of spasticity according to modified Ashworth scale (21)
- With normal I.Q. greater than 70 (assessed by psychologist),
- Can follow commands(
Key exclusion criteria (2 listed)
- Children with any other neurological impairment
- Children with audio visual impairment
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 |
|---|---|---|
| Rhythmic StabilizationRhythmic Stabilization Program for Children with Cerebral Palsy Objective: Enhance upper extremity strength and stability through rhythmic stabilization exercises. Program Overview: Duration: 30-minute sessions Frequency: Once per week for 6 weeks Exercise Steps: Positioning: The child positions their upper extremity within their available range of motion. Isometric Contraction: The child holds an isometric contraction, maintaining the position without movement. Therapist's Role: Apply resistance that is sufficient to elicit a reaction but not enough to disrupt the isometric contraction. Progression: Gradually increase the duration of the isometric hold. Increase the amount of resistance applied. Decrease the contact area between the therapist's hands and the child's upper extremity to enhance stability challenges. Monitoring and Adjustments: Assess the child's ability to maintain the contraction and adapt the resistance and support as needed. Encourage the child's engagement. | Other | Rhythmic Stabilization group |
| Ball BalancingBall Balancing Program Objective: Improve balance and stability. Equipment: 48-inch gymnastic ball Program Details: * Duration: 6 weeks * Frequency: As needed Steps: 1. Initial Balance: * Eyes Open: Balance on hands for 10 seconds. * Progression: Increase to 3-5 repetitions of 60 seconds. 2. Eyes Closed: Repeat the above exercise with eyes closed. 3. Variations: * Both Hands on One Ball * Each Hand on Separate Balls * Weaker Arm on One Ball 4. Body Positions: Progress through four body positions with eyes open, then closed. 5. Correction: If the child misses a position, they open their eyes and reposition actively. | Other | Ball Balancing group |
Primary outcome
QUEST ( Quality of Upper Extremity Skills Test)
Time frame: 6 weeks
The Quality of Upper Extremity Skills Test (QUEST) is a reliable and valid tool that assesses hand function and movement patterns in children with cerebral palsy. It can be used with children aged 6 to 12 years (23). The test is conducted in a play environment and consists of 34 activity items. The test assesses four domains: Dissociated movements, Grasp, Protective extension. Reliability is 0.96 and validity is 0.84.
SHUEE Scale
Time frame: 6 weeks
The Shriners Hospital for Children Upper Extremity Evaluation (SHUEE) is a video-based tool for the assessment of upper extremity function in children with hemiplegic cerebral palsy. This tool includes spontaneous functional analysis and Effects of Rhythmic Stabilization versus Ball Balancing on Spastic CP 3dynamic positional analysis and assesses the ability to perform grasp and release. The validity is 0.47 and reliability is 0.99
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 5 Nov 2024.
- Background: PubMed 32206590Patel DR, Neelakantan M, Pandher K, Merrick J. Cerebral palsy in children: a clinical overview. Transl Pediatr. 2020 Feb;9(Suppl 1):S125-S135. doi: 10.21037/tp.2020.01.01.
- Individual participant dataSharing planned: No
Related trials for Spastic Cerebral Palsy (sCP)
Not yet recruitingObservational study
Bilateral Asymmetry of Respiratory Muscle Activity During Breathing in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy (sCP)
Not yet recruiting
tDCS and Bi-manual Training in Cerebral Palsy
Cerebral Palsy (CP), Unilateral Cerebral Palsy
RecruitingObservational study
Botulinum Neurotoxin for Children With CP: a Delicate Balance Between Clinical Benefits and Muscular Harm
Spastic Cerebral Palsy (sCP)
Active, not recruiting
Effect of SCS Technique on Oromotor Skills in Children With CP
Sialorrhea, Spastic Cerebral Palsy (sCP)
Not yet recruiting
Virtual Reality Combined With Bobath Therapy for Spastic Cerebral Palsy
Spastic Cerebral Palsy (sCP)
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.
Masifah Kashif, 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 Rhythmic Stabilization and Ball Balancing 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 5 inclusion and 2 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 5 Nov 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?
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 Imran Amjad, PhD (9233224390125, Imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUEST ( Quality of Upper Extremity Skills Test) (time frame: 6 weeks). 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 NCT06673849, 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 Nov 2024.