Cerebral PalsyNCT06244095
Effects of Perturbation Therapy and Trunk Control Training
A study testing Perturbation Therapy in people with Cerebral Palsy, run by Riphah International University at 1 site in Pakistan.
Trial summary
A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Perturbation Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2023to 5 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Kids that suffer from cerebral palsy.
- Ages span from 5 to 10 years.
- Both males and females were represented.
- During the preceding half-year, there was no orthopedic surgery or spasticity-reduction intervention.
- No significant lower limb muscular contraction
Who cannot join
- Individuals suffering from sensory, proprioceptive, cognitive, and perceptual impairments, as well as those with contractures.
- Any neurological disease that impairs balance, including orthopedic disorders
- Individual experiencing seizures and has undergone any prior surgical treatments.
- Uncorrected visual issues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Perturbation and Trunk Control Training in Children With Cerebral Palsy
A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or somatosensory perturbations caused by muscle vibrations. The body's reactions to these sensory perturbations may be based on the perception of instability rather than actual imbalance. Trunk control plays a vital role in various aspects of daily life, including balance, walking, and overall functional abilities. Children with cerebral palsy (CP), who experience limitations in their ability to move, often expend more energy compared to their healthy peers.
Read the detailed description
This study will be randomized clinical trial used to compare the effects of Perturbation and trunk control training in children with Cerebral Palsy. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre-assessment will be done using Berg balance scale, functional Independent measures and TUG test as objective measurements. Subjects in one group will be treated using Perturbation therapy and the other one will be treated with Trunk control training. Both groups had three treatment sessions per week, for 4 weeks, and the total time for every session was about 30-45 minutes. A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or somatosensory perturbations caused by muscle vibrations. The body's reactions to these sensory perturbations may be based on the perception of instability rather than actual imbalance. On the other hand, "mechanical perturbations" physically displace the body segments, potentially leading to a shift in the overall center of mass or actual imbalance. Even small displacements of a single body segment, like the head, can elicit minor muscle responses throughout the body
- Conditions
- Cerebral Palsy
- Being tested
- Perturbation Therapy, Trunk Control Therapy
- Keywords
- Cerebral Palsy, Perturbation Therapy, Trunk control training.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perturbation TherapyOther
The applicants were instructed to perform various exercises, including rotating their trunks, tossing a ball, and maintaining pelvis neutrality. They were also asked to reach the toy sideways with one hand. The 6-week intervention was conducted four days a week for 60 minutes each day, focusing on trunk rotation, standing, tossing, and catching the ball in various directions. The training sessions lasted for 20 minutes each.
Trunk Control TherapyOther
For the duration of each session, the manual pushes and pulls were administered around once per minute and lasted for 20 minutes. A platform that can be moved in four directions.Choosing to step and stroll when there is an outside disturbance. When routine motions such as sit-to-stand transitions, disruptions are applied when standing, walking, or other activities. Training with continuous disruptions simulates scenarios such as uneven terrain. Both rope and cable excursions are above ground and last for 20 minutes. Briefly explain the platform to the participants. Asked the participants to push the torso and waist against the wall during the session. Emerging barriers during training sessions like small obstacles (e.g. pair of bricks) then Lean the participants with the support of the therapist and let them go. Asked them to Step on a mushy or slick surface in session for 20 minutes. Each intervention session took place for 60 minutes per day four days of week for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation Therapy | Experimental | Perturbation Therapy will be given to this group. Receives: Other: Perturbation Therapy |
| Trunk Control Therapy | Active comparator | Trunk control activities will be given to this group. Receives: Other: Trunk Control Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric Berg balance scale (PBBS)
BBS is 14 Item rating 5-point ordinal Scale, used to evaluate the balance in elderly population and other neurological conditions. It is easy to administer and doesn't require specialized training and takes 15- 20 mins. The maximum scoring in BBS is 56.
Measured: 6weeks
Functional Independent Measures (FIM
The Functional Independence Measure (FIM) provides a seven level ordinal scale for measuring functional performance on 18 activities considered essential for daily living. In routine practice, the scores on the individual activities are usually summed giving a total FIM score that ranges from 18 to 126.
Measured: 6weeks
Timed Up and Go Test (TUGT)
It is prognostic test to assess mobility and to identify the individuals with a risk of fall. TUG is time performance of getting up from chair, walking 3 m, turning around and walking back to sit down again. Timed Up and Go test is recommended by American Geriatrics Society, British Geriatric Society for screening risk of falls. An older who takes more than 12 seconds to complete the TUG is at the highest risk for falling
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start28 Nov 2023
- Primary completion5 Feb 2024
- Study completion5 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zirwa Afzal, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244095
- Sponsor's protocol ID
- REC/RCR&AHS/23/0737
- Status last verified
- Jun 2024
- First submitted
- 25 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
Horak FB, Earhart GM, Dietz V. Postural responses to combinations of head and body displacements: vestibular-somatosensory interactions. Exp Brain Res. 2001 Dec;141(3):410-4. doi: 10.1007/s00221-001-0915-6.
PubMed 11715086
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
- Comparative Effects of Perturbation and Trunk Control Training in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06244095
- Acronym / sponsor ID
- REC/RCR&AHS/23/0737
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Perturbation Therapy, Trunk control training.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 5 Feb 2024 (actual)
- Study completion
- 5 Feb 2024 (actual)
- First posted
- 6 Feb 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.
A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or somatosensory perturbations caused by muscle vibrations. The body's reactions to these sensory perturbations may be based on the perception of instability rather than actual imbalance. Trunk control plays a vital role in various aspects of daily life, including balance, walking, and overall functional abilities. Children with cerebral palsy (CP), who experience limitations in their ability to move, often expend more energy compared to their healthy peers.
Detailed description
This study will be randomized clinical trial used to compare the effects of Perturbation and trunk control training in children with Cerebral Palsy. Subjects meeting the predetermined inclusion and exclusion criteria will be divided into two groups using lottery method. Pre-assessment will be done using Berg balance scale, functional Independent measures and TUG test as objective measurements. Subjects in one group will be treated using Perturbation therapy and the other one will be treated with Trunk control training. Both groups had three treatment sessions per week, for 4 weeks, and the total time for every session was about 30-45 minutes. A postural perturbation refers to unexpected change in conditions that upsets the body's harmony and displaces its posture. These perturbations can be sensory in nature, such as vestibular perturbations resulting from electrical stimulation, visual perturbations caused by a moving room or graphical images, or somatosensory perturbations caused by muscle vibrations. The body's reactions to these sensory perturbations may be based on the perception of instability rather than actual imbalance. On the other hand, "mechanical perturbations" physically displace the body segments, potentially leading to a shift in the overall center of mass or actual imbalance. Even small displacements of a single body segment, like the head, can elicit minor muscle responses throughout the body
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perturbation Therapy | Experimental | Other: Perturbation TherapyPerturbation Therapy will be given to this group. |
| Trunk Control Therapy | Active comparator | Other: Trunk Control TherapyTrunk control activities will be given to this group. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Kids that suffer from cerebral palsy.
- Ages span from 5 to 10 years.
- Both males and females were represented.
- During the preceding half-year, there was no orthopedic surgery or spasticity-reduction intervention.
- No significant lower limb muscular contraction
Key exclusion criteria (4 listed)
- Individuals suffering from sensory, proprioceptive, cognitive, and perceptual impairments, as well as those with contractures.
- Any neurological disease that impairs balance, including orthopedic disorders
- Individual experiencing seizures and has undergone any prior surgical treatments.
- Uncorrected visual issues
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 |
|---|---|---|
| Perturbation TherapyThe applicants were instructed to perform various exercises, including rotating their trunks, tossing a ball, and maintaining pelvis neutrality. They were also asked to reach the toy sideways with one hand. The 6-week intervention was conducted four days a week for 60 minutes each day, focusing on trunk rotation, standing, tossing, and catching the ball in various directions. The training sessions lasted for 20 minutes each. | Other | Perturbation Therapy |
| Trunk Control TherapyFor the duration of each session, the manual pushes and pulls were administered around once per minute and lasted for 20 minutes. A platform that can be moved in four directions.Choosing to step and stroll when there is an outside disturbance. When routine motions such as sit-to-stand transitions, disruptions are applied when standing, walking, or other activities. Training with continuous disruptions simulates scenarios such as uneven terrain. Both rope and cable excursions are above ground and last for 20 minutes. Briefly explain the platform to the participants. Asked the participants to push the torso and waist against the wall during the session. Emerging barriers during training sessions like small obstacles (e.g. pair of bricks) then Lean the participants with the support of the therapist and let them go. Asked them to Step on a mushy or slick surface in session for 20 minutes. Each intervention session took place for 60 minutes per day four days of week for 6 weeks. | Other | Trunk Control Therapy |
Primary outcome
Pediatric Berg balance scale (PBBS)
Time frame: 6weeks
BBS is 14 Item rating 5-point ordinal Scale, used to evaluate the balance in elderly population and other neurological conditions. It is easy to administer and doesn't require specialized training and takes 15- 20 mins. The maximum scoring in BBS is 56.
Functional Independent Measures (FIM
Time frame: 6weeks
The Functional Independence Measure (FIM) provides a seven level ordinal scale for measuring functional performance on 18 activities considered essential for daily living. In routine practice, the scores on the individual activities are usually summed giving a total FIM score that ranges from 18 to 126.
Timed Up and Go Test (TUGT)
Time frame: 6weeks
It is prognostic test to assess mobility and to identify the individuals with a risk of fall. TUG is time performance of getting up from chair, walking 3 m, turning around and walking back to sit down again. Timed Up and Go test is recommended by American Geriatrics Society, British Geriatric Society for screening risk of falls. An older who takes more than 12 seconds to complete the TUG is at the highest risk for falling
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 11715086Horak FB, Earhart GM, Dietz V. Postural responses to combinations of head and body displacements: vestibular-somatosensory interactions. Exp Brain Res. 2001 Dec;141(3):410-4. doi: 10.1007/s00221-001-0915-6.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Intrathecal Baclofen and Pediatric Dystonia
Dystonic Cerebral Palsy
Enrolling by invitationPhase 2
The Progressive Supranuclear Palsy Clinical Trial Platform - Regimen B: LM11A-31
PSP - Progressive Supranuclear Palsy
RecruitingPhase 1/2
Tributyrin for Progressive Supranuclear Palsy (PSP): Virtual Trial
Parkinson Disease, Multiple System Atrophy
Not yet recruiting
Effect of Robotic Gloves Training on Upper Limb Coordination, Selective Motor Control and Activities of Daily Living in Children With Hemiparetic Cerebral Palsy
Hemiplegic Cerebral Palsy
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.
Zirwa Afzal, 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 Perturbation 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 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 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?
Pediatric Berg balance scale (PBBS) (time frame: 6weeks). 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 NCT06244095, 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.