NCT07157488

Brief Summary

Dual task training enhances gross motor function, reduce fatigue and minimize cognitive motor interference in children with diplegic cerebral palsy by promoting neuroplasticity and improving dual task processing. Vestibular stimulation improve balance triggering the vestibulospinal reflex, which play a key role in maintaining posture and reducing the risk of fall. Integrating dual task training with vestibular stimulation can provide a more holistic rehabilitation strategy by enhancing balance and posture stability through improved vestibular system activation, supporting motor and cognitive coordination by challenging the brain to handle tasks concurrently, and boosting functional mobility by mimicking everyday situations that require divided attention. This RCT evaluates its effectiveness in optimizing motor-cognitive integration, functional mobility and endurance compared to conventional motor training approaches.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

3 months

First QC Date

August 27, 2025

Last Update Submit

August 27, 2025

Conditions

Keywords

Diplegic cerebral palsyDual task trainingVestibular stimulation

Outcome Measures

Primary Outcomes (1)

  • Gross Motor Function Measure (GMFM-88)

    The GMFM-88 is a standardized observational instrument designed to measure changes in gross motor function in children with cerebral palsy. Scores range from 0-100, with higher scores indicating better gross motor performance.

    Baseline and at 12 weeks (post-intervention, within 1 week of completion)

Study Arms (2)

Conventional Physical Therapy With Dual Task Training

ACTIVE COMPARATOR

Participants receive conventional physical therapy combined with dual task training. Warm-up (10 min): Trunk and lower extremity ROM exercises (Lee et al., 2021). Conventional PT (20 min): Wide leg squatting, hip flexion/extension, hip abduction/adduction, knee extension/flexion with ankle weights (Uysal et al., 2024). Dual Task Training (20 min): Balance activities (semi-tandem stance, tiptoe, heel stance, one-leg stance, line walking) combined with cognitive tasks (verbal fluency, simple math, memory recall, daily routine recall). Session Duration: 50 minutes, 3 times/week for 12 weeks.

Behavioral: Conventional Physical Therapy With Dual Task TrainingBehavioral: Dual Task Training With Vestibular Stimulation

Dual Task Training With Vestibular Stimulation

EXPERIMENTAL

Participants receive dual task training combined with vestibular stimulation exercises. Warm-up (10 min): Trunk and lower extremity ROM exercises (Lee et al., 2021). Dual Task Training (20 min): Same protocol as Arm 1 (balance + cognitive tasks). Vestibular Stimulation (20 min): Sliding activity on physio roll (10 repetitions) and vertical bouncing while seated on physio roll for 10 minutes (Parashar et al., 2017). Session Duration: 50 minutes, 3 times/week for 12 weeks.

Behavioral: Conventional Physical Therapy With Dual Task TrainingBehavioral: Dual Task Training With Vestibular Stimulation

Interventions

Participants undergo a 50-minute session, 3 times/week for 12 weeks. Warm-up (10 min): Trunk and lower extremity ROM exercises (Lee et al., 2021). Conventional PT (20 min): Wide leg squatting, hip flexion/extension, hip abduction/adduction, knee extension/flexion with ankle weights (Uysal et al., 2024). Dual Task Training (20 min): Balance activities (semi-tandem stance, tiptoe, heel stance, one-leg stance, line walking) with cognitive activities (verbal fluency, simple math, memory recall, daily routine recall).

Conventional Physical Therapy With Dual Task TrainingDual Task Training With Vestibular Stimulation

Participants undergo a 50-minute session, 3 times/week for 12 weeks. Warm-up (10 min): Trunk and lower extremity ROM exercises (Lee et al., 2021). Dual Task Training (20 min): Same as Intervention 1 (balance + cognitive tasks). Vestibular Stimulation (20 min): Sliding activity on physio roll (10 repetitions) and vertical bouncing on physio roll for 10 minutes (Parashar et al., 2017).

Conventional Physical Therapy With Dual Task TrainingDual Task Training With Vestibular Stimulation

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- Diagnosis of diplegic cerebral palsy (confirmed by physician/therapist).
  • Age between 6-12 years.
  • Gross Motor Function Classification System (GMFCS) levels II-III.
  • Ability to walk with or without assistive devices.
  • Stable medical condition for the past 6 months.
  • Parental/guardian consent to participate.

You may not qualify if:

  • History of recent orthopedic surgery (within the past 6 months).
  • Botulinum toxin injections within the past 6 months.
  • Severe uncontrolled epilepsy or other uncontrolled medical conditions.
  • Severe cognitive impairment preventing ability to follow instructions.
  • Significant visual, auditory, or vestibular disorders unrelated to cerebral palsy.
  • Participation in another interventional clinical study within the last 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Aqsa Majeed

Study Record Dates

First Submitted

August 27, 2025

First Posted

September 5, 2025

Study Start

September 1, 2025

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share