- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07568808
Core Stabilization and Kinesthetic Training in Diplegic CP
Comparative Effects of Core Stabilization Exercises and Kinesthetic Training in Diplegic Cerebral Palsy
This randomized controlled trial aimed to compare the effects of core stabilization exercises (CSE) and kinesthetic training (KT) on postural control in children with spastic diplegic cerebral palsy (GMFCS Level III), aged 4-8 years. Cerebral palsy was recognized as a non-progressive neurological disorder that affects movement, posture, and motor function, often leading to impaired balance, reduced trunk control, and decreased functional independence. Postural instability was identified as a key concern in diplegic CP, and effective rehabilitation strategies were considered essential to improve mobility and daily functioning. Core stabilization exercises focused on strengthening deep trunk muscles to enhance stability and alignment, whereas kinesthetic training emphasized proprioceptive awareness and neuromuscular coordination to improve movement accuracy and balance. Although both interventions had shown benefits individually, their comparative effectiveness remained unclear.
A total of 32 participants were recruited using purposive sampling and were randomly assigned into two groups: CSE (n=16) and KT (n=16). Both groups received conventional physiotherapy for 15 minutes followed by 30 minutes of their respective interventions, three times per week for 12 weeks. Outcome assessment was conducted at baseline, mid-intervention (6 weeks), and post-intervention (12 weeks) using the Pediatric Berg Balance Scale (PBBS) to evaluate static and dynamic balance. Data were analyzed using SPSS, applying paired t-tests for within-group comparisons and independent t-tests for between-group analysis, with significance set at p < 0.05. This study aimed to determine the more effective intervention for improving balance and functional outcomes, thereby supporting evidence-based clinical practice in pediatric rehabilitation.
A total of 32 participants will be recruited using purposive sampling and randomly assigned into two groups: CSE (n=16) and KT (n=16). Both groups will receive conventional physiotherapy for 15 minutes followed by 30 minutes of their respective interventions, three times per week for 12 weeks. Outcome assessment will be conducted at baseline, mid-intervention (6 weeks), and post-intervention (12 weeks) using the Pediatric Berg Balance Scale (PBBS) to evaluate static and dynamic balance. Data will be analyzed using SPSS, applying paired t-tests for within-group comparisons and independent t-tests for between-group analysis, with significance set at p < 0.05. This study aims to determine the more effective intervention for improving balance and functional outcomes, thereby supporting evidence-based clinical practice in pediatric rehabilitation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized controlled trial was conducted to compare the effects of core stabilization exercises (CSE) and kinesthetic training (KT) on postural control in children diagnosed with spastic diplegic cerebral palsy classified at Gross Motor Function Classification System (GMFCS) Level III, aged between 4 and 8 years. Children within this classification typically demonstrated limitations in independent mobility and required assistive devices for ambulation, with notable impairments in trunk control and balance.
Postural instability in this population was identified as a major contributor to functional limitations, affecting activities such as sitting, standing, and transitional movements. Impaired trunk stability and reduced proprioceptive input were considered key factors influencing balance deficits. Therefore, targeted interventions focusing on trunk control and sensory-motor integration were explored to enhance postural regulation and functional independence.
Core stabilization exercises were implemented with the aim of improving activation, strength, and endurance of deep trunk musculature, including the transversus abdominis, multifidus, and pelvic stabilizers. These exercises emphasized controlled movements, alignment, and postural symmetry in various positions such as supine, sitting, and supported standing. Progression was based on the child's ability to maintain stability with reduced external support.
Kinesthetic training was designed to enhance proprioceptive awareness, joint position sense, and neuromuscular coordination. Activities included weight-shifting, balance challenges on stable and unstable surfaces, guided movement tasks, and functional reaching exercises. The intervention focused on improving the child's ability to perceive and adjust body position in space, thereby facilitating better motor control and balance responses.
Participants were recruited through purposive sampling from pediatric rehabilitation settings and were randomly allocated into two intervention groups using a simple randomization method. Each group consisted of 16 participants. Both groups received a standardized conventional physiotherapy program to ensure consistency in baseline care. This included stretching of spastic muscle groups, range-of-motion exercises, and facilitation of functional movements.
Following conventional therapy, participants underwent their assigned intervention (CSE or KT) for 30 minutes per session. The intervention was delivered three times per week over a period of 12 weeks. Sessions were supervised by trained physiotherapists to ensure adherence, safety, and appropriate progression of exercises.
Outcome measures were recorded at three time points: baseline (prior to intervention), mid-intervention (6 weeks), and post-intervention (12 weeks). Postural control and balance were assessed using the Pediatric Berg Balance Scale (PBBS), a validated tool for measuring both static and dynamic balance in pediatric populations. The scale included functional tasks such as sitting, standing, reaching, turning, and transferring, with scores reflecting the child's level of independence and stability.
Data were analyzed using statistical software. Within-group comparisons were performed to assess changes over time, while between-group comparisons were conducted to determine differences in effectiveness between the two interventions. Statistical significance was set at p < 0.05.
The findings of this study were intended to provide evidence regarding the relative effectiveness of core stabilization versus kinesthetic training in improving balance in children with spastic diplegic cerebral palsy. The results were expected to contribute to clinical decision-making and support the development of targeted rehabilitation protocols aimed at enhancing functional outcomes and quality of life in this population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 42000
- Sehat Medical Complex, Pediatric Rehabilitation Department, ULTH.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Spastic diplegic CP
- GMFCS Level III
- Age range: 4 to 8 years
- Must have verbal communication
- Ability to follow verbal commands
Exclusion Criteria:
- Severe cognitive impairment
- History of epilepsy or seizures in the past 3 months.
- Children with progressive neurological or genetic disorders (e.g., muscular dystrophy).
- Any acute respiratory infection or chronic pulmonary disease
- Any visual or auditory impairments
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Core Stabilization Group
Participants in this group received a core stabilization exercise program focusing on deep abdominal and back muscles.
The protocol included the plank, bird-dog, and dead bug exercises, which were performed three times per week for four weeks.
|
A 4-week exercise program focusing on deep abdominal and back muscles.
Sessions are 45 minutes each, 3 times per week.
Exercises include The Plank (front and side), Bird-Dog, and Dead Bug.
Progression will be managed by increasing hold times and repetitions as the patient's stability improves.
|
|
Experimental: Kinesthetic Training Group
Participants in this group underwent kinesthetic training aimed at improving proprioception and joint position sense.
This included weight-shifting and balance activities on stable and unstable surfaces, which were performed three times per week for four weeks.
|
A 4-week sensory-motor training program designed to improve proprioception and balance.
Sessions are 45 minutes each, 3 times per week.
Activities include single-limb standing, weight shifting on stable and unstable surfaces (like foam pads), and coordinated limb movements to enhance joint position sense and postural control.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Control is measured using the PBBS to evaluate both static and dynamic postural stability.
Time Frame: 6 months
|
The Pediatric Berg Balance Scale (PBBS) is a standardized clinical assessment used to measure functional balance and postural control in children with motor challenges.
It consists of 14 distinct tasks that mimic activities of daily living, including the ability to sit and stand without support, transfer between chairs, reach forward, and pick up objects from the floor.
Each task is evaluated on a 5-point scale ranging from 0 to 4, where a higher score reflects a greater level of independence and stability.
With a maximum total score of 56, the PBBS serves as a reliable tool for tracking a child's progress over time and determining the effectiveness of therapeutic interventions.
In this clinical trial, the scale is utilized at baseline, week 6, and week 12 to provide a clear quantitative record of the participant's balance improvements.
|
6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Eliasson, A. C., Krumlinde-Sundholm, L., Rösblad, B., Beckung, E., Arner, M., Ohrvall, A. M., & Rosenbaum, P. (2006). The Manual Ability Classification System (MACS) for children with cerebral palsy: scale development and evidence of validity and reliability. Dev Med Child Neurol, 48(7), 549-554.
- Akay, T., & Murray, A. J. (2021). Relative contribution of proprioceptive and vestibular sensory systems to locomotion: opportunities for discovery in the age of molecular science. International Journal of Molecular Sciences, 22(3), 1467.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UOL/IREB/25/12/0035.
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 Diplegic Cerebral Palsy
-
Ankara City Hospital BilkentRecruitingCerebral Palsy (CP) | Cerebral Palsy, Spastic, Diplegic | Diplegic Cerebral Palsy With Spasticity | Transcranial Magnetic StimilationTurkey (Türkiye)
-
Cairo UniversityActive, not recruitingDiplegic Spastic Cerebral PalsyEgypt
-
Suleyman Demirel UniversityCompletedCerebral Palsy | Hemiplegic Cerebral Palsy | Spastic Diplegia Cerebral PalsyTurkey (Türkiye)
-
Kafrelsheikh UniversityNot yet recruitingDiplegic Cerebral Palsy With Spasticity
-
MTI UniversityEnrolling by invitationSpastic Diplegic Cerebral PalsyEgypt
-
Inonu UniversityRecruitingDiplegic Cerebral Palsy With Spasticity | Motor İmagery AbilityTurkey (Türkiye)
-
Lahore University of Biological and Applied SciencesNot yet recruitingSpastic Diplegia Cerebral PalsyPakistan
-
University of LahoreNot yet recruitingDiplegic Cerebral Palsy
-
Cairo UniversityRecruitingSpastic Diplegic Cerebral PalsyEgypt
-
Eastern Mediterranean UniversityCompletedDiplegic Cerebral Palsy With SpasticityPalestinian Territory, occupied
Clinical Trials on Core Stabilization Exercises
-
Fenerbahce UniversityCompletedExercise | ElderlyTurkey
-
Riphah International UniversityNot yet recruitingSacroiliac Joint DysfunctionPakistan
-
Dow University of Health SciencesRecruiting
-
Lahore University of Biological and Applied SciencesNot yet recruitingNon Specific Low Back PainPakistan
-
Medipol UniversityActive, not recruitingSedentary Behavior | Core StabilizationTurkey
-
Bezmialem Vakif UniversityCompletedAdolescent Idiopathic ScoliosisTurkey (Türkiye)
-
Hacettepe UniversityCompleted
-
Running Injury ClinicAlberta Health services; WCB AlbertaUnknownLow Back Pain, MechanicalCanada
-
Gazi UniversityAtaturk University; Erzurum Technical UniversityCompletedLow Back Pain | Lumbar Disc HerniationTurkey
-
Yeditepe UniversityIstanbul UniversityCompleted