Cerebral PalsyNCT06197594
Effects of PNF and Rebound Therapy on Trunk Control in CP
A study testing Proprioceptive neuromuscular facilitation techniques and Rebound Therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Cerebral palsy is a group of upper motor neuron syndromes with acquired disorders of early brain development .It effects the person's ability to move and maintain balance and posture. It is the most common motor disability of childhood. 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?
- Proprioceptive neuromuscular facilitation techniques and Rebound Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2023to 6 Feb 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
- Both gender
- Children from 6 years to 12 years of age will be included
- Degree of spasticity ranged from 1 and 1+ according to modified Ashworth scale
- According to gross motor functional classification system children were categorized on level I -II
- Those children should understand and follow simple orders.
Who cannot join
- Child having any fixed deformity of both hands and feet.
- Having hearing or visual disability
- Having infectious disease or any open wound
- Seizures
- Other spinal deformities
- Any fracture
- Unstable cardiac status, Fever greater than 38 degrees Celsius, Any chest infection
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 Proprioceptive Neuromuscular Facilitation Techniques With and Without Rebound Therapy on Trunk Control in Children With Cerebral Palsy
Cerebral palsy is a group of upper motor neuron syndromes with acquired disorders of early brain development .It effects the person's ability to move and maintain balance and posture. It is the most common motor disability of childhood. Proprioceptive neuromuscular facilitation integration pattern stimulates the proprioceptors with in the muscle and tendon to enhance the performance flexibility, balance and helps in trunk mobility. The motor control movement pattern is facilitated by the dynamic and assistive active resistant progressions regaining motor control. Rebound therapy is used to facilitate movement, promote balance, helps in increase or decrease in muscle tone and promotes sensory integration.
This study will evaluate the effects of PNF techniques with and without rebound therapy on trunk control in children with cerebral palsy. It is randomized controlled trial.34 children with cerebral palsy will participate in this study. The participants will be randomized into control group A (n=17) and experimental group (n =17).Only those children will be included who fulfill inclusion criteria. That is both gender, age range 6 to 12 years, having GMFM score of I -II .Those having cognitive and learning difficulties, having age range out of 6 to 12 years. Data will be analyzed through SPSS 29. The control group will practice PNF techniques for trunk control while experimental group will practice rebound therapy along with PNF exercises for trunk control .Both group will receive 45 min session, 5 days a week for 6 weeks. TCMS and TUG scale will be used.
Read the detailed description
Intervention
GROUP A (experimental group)
After giving baseline therapy experimental group will be given PNF based exercises for trunk control along with rebound therapy .duration will be 45 minutes, 5 session per week for 6 weeks.
PNF exercises will be;
Resist the person's concentric contraction while they move into sitting .Resist the eccentric control as they lie down. Balancing using stabilizing reversals or rhythmic stabilization to increase trunk stability .Resist the shoulder pelvis and head. For Trunk exercises: use dynamic reversals (slow reversals) and combination of isotonic to increase patient trunk strength and coordination .Resist at scapula and lifting combinations to get added irradiation. Trunk flexion and extension. Reaching forward and to the side with return, this requires hip flexion, extension ,lateral motion and rotation with the trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting.
REBOUND THERAPY
Rebound therapy session including lying down on trampoline bouncing created by therapist.
It will be 10 repetitions. .Hip kneeling bouncing with physio balls. Standing bouncing with physio balls .Jumping on trampoline. Learning front drops, seat drops, and other function movements will be given for 5 minutes.
GROUP B (control group)
The control group will only be given PNF based trunk exercises. PNF exercises will be; Resist the person's concentric contraction while they move into sitting .Resist the eccentric control as they lie down. Balancing using stabilizing reversals or rhythmic stabilization to increase trunk stability .Resist the shoulder pelvis and head. For Trunk exercises: use dynamic reversals (slow reversals) and combination of isotonic to increase patient trunk strength and coordination .Resist at scapula and lifting combinations to get added irradiation. Trunk flexion and extension. Reaching forward and to the side with return, this requires hip flexion , extension ,lateral motion and rotation with the trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting.
- Conditions
- Cerebral Palsy
- Being tested
- Proprioceptive neuromuscular facilitation techniques, Rebound Therapy
- Keywords
- Cerebral palsy, PNF, Rebound therapy,Trunk Control
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proprioceptive neuromuscular facilitation techniquesOther
Proprioceptive neuromuscular facilitation techniques
Rebound TherapyOther
Rebound Therapy
| Study group | Role | What they receive |
|---|---|---|
| Proprioceptive neuromuscular facilitation techniques | Experimental | GROUP A (experimental group)
PNF based exercises for trunk control duration 45 min 5 session/week for 6 weeks; Resist person concentric contraction while move in sitting .Resist eccentric control as th lie down. Balance using stabilizing reversals or rhythmic stabilization .Resist shoulder pelvis ,head.Trunk exercises dynamic reversals and combination of isotonic to increase trunk strength and coordination .Resist at scapula and lifting combinations for irradiation. Trunk flexion and extension. Reaching forward and to side with return,for this hip flexion, extension ,lateral motion and rotation with the trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting Receives: Other: Proprioceptive neuromuscular facilitation techniques |
| Rebound Therapy | Active comparator | Rebound Therapy lying down on trampoline bouncing created.10 times.Hip kneeling bounce and Standing bouncing with physio balls .Jump on trampoline. Learning front drops, seat drops for 5 minutes.
Resist person concentric contraction while move into sitting .Resist eccentric control as they lie down. Balance using stabilizing reversals to increase trunk stability .Resist shoulder pelvis, head.Trunk exercises: use dynamic reversals and combination of isotonic to increase trunk strength and coordination .Resist at scapula and lifting combination for irradiation. Trunk flexion and extension. Reaching forward and to side with return,for this hip flexion , extension ,lateral motion and rotation with trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting Receives: Other: Rebound Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk control measure scale
Trunk control measuring scale TCMS:
Trunk control measuring scale is highly reliable in children with various neuromuscular disorders .It is reliable for children 5 years and older. TCMS consist of static and dynamic
sitting balance, the latter is divided into selective movement control and dynamic reaching.
TCMS is a valid and reliable tool for assessing the trunk control in children and youth with CP. The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control and 10 to the ability to perform dynamic reaching. The items are scored 0 to 3 with 0 being the inability to perform the task and 3 being the complete task performance.
Measured: 6 weeks
Timed Up and Go test
Timed Up and Go test (TUG)
It is a performance measure designed to assess the speed of a functional walk. It included stand up, walk 3 min, turn around, walk back, and sit down .It assesses lower limb mobility and function. The TUG test is reliable and responsive measure of balance and mobility for children with CP between 3 and 10 years of age and with GMFM level I- III
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 posted9 Jan 2024
- Study start1 Dec 2023
- Primary completion5 Feb 2024
- Study completion6 Feb 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 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
- Randomized Controlled trial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maidah Aiman, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197594
- Sponsor's protocol ID
- REC/RCR & AHS/23/0739
- Status last verified
- Jun 2024
- First submitted
- 26 Dec 2023
- Last updated
- 13 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Germain AM, Blackmore AM, Gibson N, Newell B, Williams SA. Effects of Adaptive Bungee Trampolining for Children With Cerebral Palsy: A Single-Subject Study. Pediatr Phys Ther. 2019 Apr;31(2):165-174. doi: 10.1097/PEP.0000000000000584.
PubMed 30865143
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Proprioceptive Neuromuscular Facilitation Techniques With and Without Rebound Therapy on Trunk Control in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06197594
- Acronym / sponsor ID
- REC/RCR & AHS/23/0739
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral palsy, PNF, Rebound therapy,Trunk Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 9 Jan 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.
Cerebral palsy is a group of upper motor neuron syndromes with acquired disorders of early brain development .It effects the person's ability to move and maintain balance and posture. It is the most common motor disability of childhood. Proprioceptive neuromuscular facilitation integration pattern stimulates the proprioceptors with in the muscle and tendon to enhance the performance flexibility, balance and helps in trunk mobility. The motor control movement pattern is facilitated by the dynamic and assistive active resistant progressions regaining motor control. Rebound therapy is used to facilitate movement, promote balance, helps in increase or decrease in muscle tone and promotes sensory integration.
This study will evaluate the effects of PNF techniques with and without rebound therapy on trunk control in children with cerebral palsy. It is randomized controlled trial.34 children with cerebral palsy will participate in this study. The participants will be randomized into control group A (n=17) and experimental group (n =17).Only those children will be included who fulfill inclusion criteria. That is both gender, age range 6 to 12 years, having GMFM score of I -II .Those having cognitive and learning difficulties, having age range out of 6 to 12 years. Data will be analyzed through SPSS 29. The control group will practice PNF techniques for trunk control while experimental group will practice rebound therapy along with PNF exercises for trunk control .Both group will receive 45 min session, 5 days a week for 6 weeks. TCMS and TUG scale will be used.
Detailed description
Intervention
GROUP A (experimental group)
After giving baseline therapy experimental group will be given PNF based exercises for trunk control along with rebound therapy .duration will be 45 minutes, 5 session per week for 6 weeks.
PNF exercises will be;
Resist the person's concentric contraction while they move into sitting .Resist the eccentric control as they lie down. Balancing using stabilizing reversals or rhythmic stabilization to increase trunk stability .Resist the shoulder pelvis and head. For Trunk exercises: use dynamic reversals (slow reversals) and combination of isotonic to increase patient trunk strength and coordination .Resist at scapula and lifting combinations to get added irradiation. Trunk flexion and extension. Reaching forward and to the side with return, this requires hip flexion, extension ,lateral motion and rotation with the trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting.
REBOUND THERAPY
Rebound therapy session including lying down on trampoline bouncing created by therapist.
It will be 10 repetitions. .Hip kneeling bouncing with physio balls. Standing bouncing with physio balls .Jumping on trampoline. Learning front drops, seat drops, and other function movements will be given for 5 minutes.
GROUP B (control group)
The control group will only be given PNF based trunk exercises. PNF exercises will be; Resist the person's concentric contraction while they move into sitting .Resist the eccentric control as they lie down. Balancing using stabilizing reversals or rhythmic stabilization to increase trunk stability .Resist the shoulder pelvis and head. For Trunk exercises: use dynamic reversals (slow reversals) and combination of isotonic to increase patient trunk strength and coordination .Resist at scapula and lifting combinations to get added irradiation. Trunk flexion and extension. Reaching forward and to the side with return, this requires hip flexion , extension ,lateral motion and rotation with the trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled trial
| Arm | Type | Receives |
|---|---|---|
| Proprioceptive neuromuscular facilitation techniques | Experimental | Other: Proprioceptive neuromuscular facilitation techniquesGROUP A (experimental group) PNF based exercises for trunk control duration 45 min 5 session/week for 6 weeks; Resist person concentric contraction while move in sitting .Resist eccentric control as th lie down. Balance using stabilizing reversals or rhythmic stabilization .Resist shoulder pelvis ,head.Trunk exercises dynamic reversals and combination of isotonic to increase trunk strength and coordination .Resist at scapula and lifting combinations for irradiation. Trunk flexion and extension. Reaching forward and to side with return,for this hip flexion, extension ,lateral motion and rotation with the trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting |
| Rebound Therapy | Active comparator | Other: Rebound TherapyRebound Therapy lying down on trampoline bouncing created.10 times.Hip kneeling bounce and Standing bouncing with physio balls .Jump on trampoline. Learning front drops, seat drops for 5 minutes. Resist person concentric contraction while move into sitting .Resist eccentric control as they lie down. Balance using stabilizing reversals to increase trunk stability .Resist shoulder pelvis, head.Trunk exercises: use dynamic reversals and combination of isotonic to increase trunk strength and coordination .Resist at scapula and lifting combination for irradiation. Trunk flexion and extension. Reaching forward and to side with return,for this hip flexion , extension ,lateral motion and rotation with trunk remaining stable Bridging exercises Lower trunk rotation .Weight shifting in long leg sitting |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Both gender
- Children from 6 years to 12 years of age will be included
- Degree of spasticity ranged from 1 and 1+ according to modified Ashworth scale
- According to gross motor functional classification system children were categorized on level I -II
- Those children should understand and follow simple orders.
Key exclusion criteria (7 listed)
- Child having any fixed deformity of both hands and feet.
- Having hearing or visual disability
- Having infectious disease or any open wound
- Seizures
- Other spinal deformities
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 |
|---|---|---|
| Proprioceptive neuromuscular facilitation techniquesProprioceptive neuromuscular facilitation techniques | Other | Proprioceptive neuromuscular facilitation techniques |
| Rebound TherapyRebound Therapy | Other | Rebound Therapy |
Primary outcome
Trunk control measure scale
Time frame: 6 weeks
Trunk control measuring scale TCMS: Trunk control measuring scale is highly reliable in children with various neuromuscular disorders .It is reliable for children 5 years and older. TCMS consist of static and dynamic sitting balance, the latter is divided into selective movement control and dynamic reaching. TCMS is a valid and reliable tool for assessing the trunk control in children and youth with CP. The TCMS scale assesses seated trunk control in three dimensions. The maximum score is 58 points where 20 points correspond to static balance, 28 to selective movement control and 10 to the ability to perform dynamic reaching. The items are scored 0 to 3 with 0 being the inability to perform the task and 3 being the complete task performance.
Timed Up and Go test
Time frame: 6 weeks
Timed Up and Go test (TUG) It is a performance measure designed to assess the speed of a functional walk. It included stand up, walk 3 min, turn around, walk back, and sit down .It assesses lower limb mobility and function. The TUG test is reliable and responsive measure of balance and mobility for children with CP between 3 and 10 years of age and with GMFM level I- III
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 13 Jun 2024.
- Background: PubMed 30865143Germain AM, Blackmore AM, Gibson N, Newell B, Williams SA. Effects of Adaptive Bungee Trampolining for Children With Cerebral Palsy: A Single-Subject Study. Pediatr Phys Ther. 2019 Apr;31(2):165-174. doi: 10.1097/PEP.0000000000000584.
- 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.
Maidah Aiman, 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 Proprioceptive neuromuscular facilitation techniques and Rebound Therapy 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 5 inclusion and 7 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 13 Jun 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?
Trunk control measure scale (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 NCT06197594, 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 13 Jun 2024.