- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06244095
Effects of Perturbation Therapy and Trunk Control Training
January 28, 2024 updated by: Riphah International University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
26
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
Study Contact Backup
- Name: Imran Amjad, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- Recruiting
- Imran Amjad
-
Contact:
- Muhammad Asif Javed, MS
- Phone Number: 03224209422
- Email: a.javed@riphah.edu.pk
-
Contact:
- Imran Amjad, PhD
- Phone Number: 923224390125
- Email: a.javed@riphah.edu.pk
-
Principal Investigator:
- Zirwa Afzal, MS*
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Perturbation Therapy
Perturbation Therapy will be given to this group.
|
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.
|
Active Comparator: Trunk Control Therapy
Trunk control activities will be given to this group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6weeks
|
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.
|
6weeks
|
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
|
6weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Zirwa Afzal, MS*, Riphah International University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 28, 2023
Primary Completion (Estimated)
February 5, 2024
Study Completion (Estimated)
February 5, 2024
Study Registration Dates
First Submitted
December 25, 2023
First Submitted That Met QC Criteria
January 28, 2024
First Posted (Estimated)
February 6, 2024
Study Record Updates
Last Update Posted (Estimated)
February 6, 2024
Last Update Submitted That Met QC Criteria
January 28, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0737
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cerebral Palsy
-
Gazi UniversityCompletedCerebral Palsy | Cerebral Palsy, Spastic | Cerebral Palsy Spastic Diplegia | Cerebral Palsy Quadriplegic | Cerebral Palsy, MonoplegicTurkey
-
Northwestern UniversityActive, not recruitingCerebral Palsy | Diplegic Cerebral Palsy | Bilateral Cerebral PalsyUnited States
-
Centre Médico-Chirurgical de Réadaptation des Massues...RecruitingCerebral Palsy, Dyskinetic | Cerebral Palsy, Spastic | Infantile Hemiplegic Cerebral PalsyFrance
-
St Mary's University CollegeUniversity of GloucestershireUnknownCerebral Palsy | Cerebral Palsy Ataxic | Cerebral Palsy, MixedUnited Kingdom
-
Hilde FeysHasselt University; ETH Zurich; Curtin UniversityRecruitingHemiplegic Cerebral Palsy | Cerebral Palsy, SpasticBelgium
-
University of California, San FranciscoNational Institutes of Health (NIH)RecruitingDystonic Cerebral Palsy | Dyskinetic Cerebral PalsyUnited States
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
East Carolina UniversityRecruitingHemiplegic Cerebral Palsy | Unilateral Cerebral Palsy | Remote Ischemic ConditioningUnited States
-
October 6 UniversityCompletedSpastic Cerebral Palsy | Spastic Hemiplegic Cerebral PalsyEgypt
-
Marmara UniversityUnknownCerebral Palsy, Spastic | Cerebral Palsy, Spastic, DiplegicTurkey
Clinical Trials on Perturbation Therapy
-
Medipol UniversityRecruiting
-
University of FloridaNational Institutes of Health (NIH); National Institute on Deafness and Other...WithdrawnStroke | Dysphagia | Spinocerebellar Ataxia | Dysarthria | Cerebral Stroke
-
Mahatma Gandhi Institute of Medical SciencesCompleted
-
Barzilai Medical CenterCompletedAccidental FallsIsrael
-
VA Office of Research and DevelopmentCompleted
-
Barzilai Medical CenterCompletedAccidental FallsIsrael
-
Soroka University Medical CenterCompleted
-
Georgia State UniversityNational Institutes of Health (NIH); Alzheimer's AssociationRecruiting
-
Suleyman Demirel UniversityUnknown
-
University of Illinois at ChicagoNational Institute on Aging (NIA)Completed