Effects of Vestibular Stimulation in Addition to Conventional Physiotherapy in Improving Gross Motor Function and Mobility in Children With Spastic Diplegic Cerebral Palsy

NCT07712315 | Completed

• 1 other identifier: IIUI/RERC/ADT/2026/01/215
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

This was a RCT to determine and compare the effects of vestibular stimulation in addition to conventional physical therapy on gross motor function and mobility in children with spastic diplegic cerebral palsy.

Conditions

Spastic Diplegic Cerebral Palsy

Outcome Measures

Primary Outcomes (3)

• Gross Motor Function Measure (GMFM-88)

  Gross Motor Function Measure (GMFM-88) will be used to assess the progression of gross motor function over time in cerebral palsy affected children. The original GMFM version has 88-items and divided into five dimensions. each item scored on a 4-point ordinal scale of 0 to 3, where: * 0 shows that the participant does not begin the activity * 1 show that the participant initiates the activity (completes \< 10% of the activity) * 2 show that the participant completes the activity partially (performed from 10 to 99% of the activity) * 3 show that the participant finishes the activity (100%) * NT show that the participant was not tested For each item, maximum of three trials is permitted and the best one will be recorded. Scores for each group are expressed as a percentage of the its highest score and the total score is calculated by summing the percentage scores for each of the five groups/dimensions.

  Assessment was performed at baseline and after 6 weeks of intervention.

• 10-Meter Walk Test (10MWT)

  The 10 Meter Walk Test was used to determine functional mobility in children with spastic diplegic cerebral palsy. The test will be conducted on a 14 m pathway, including the starting and ending points, with a 2 m walk-in section. The time taken to reach the midpoint of the 10 m walk will be recorded.

  Assessment was performed at baseline and after 6 weeks of intervention

• Timed Up and Go (TUG) test

  Mobility of children was evaluated via timed get up and go (TUG) test and its results were recorded.(15) In this test, the duration of standing up from an armchair, walking up to 3 m, turn walk back, and sitting on the chair was measured. (16) Interpretations are as follow: * \<10 seconds = normal * \< 20 seconds = good mobility, can go out alone, mobile without a gait aid. * \< 30 seconds = problems, cannot go outside alone, requires a gait aid.

  Assessment was performed at baseline and after 6 weeks of intervention.

Study Arms (2)

Experimental Group A received Vestibular Stimulation along with Conventional therapy.

EXPERIMENTAL

Participants in this group received Vestibular Stimulation along with Conventional therapy.

Other: Experimental Group A received Vestibular Stimulation along with Conventional therapy.

Control Group B received Conventional physiotherapy alone.

ACTIVE COMPARATOR

Participants in this group received Conventional physiotherapy alone

Other: Control Group B received Conventional physiotherapy alone.

Interventions

Control Group B received Conventional physiotherapy alone. OTHER

Control Group B received Conventional physiotherapy alone which includes Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.

Control Group B received Conventional physiotherapy alone.

Experimental Group A received Vestibular Stimulation along with Conventional therapy. OTHER

Experimental Group A received Vestibular Stimulation along with Conventional therapy. Vestibular stimulation included Multi-directional swinging , Trampoline jumps , Rocking movement , Gaze stabilization exercises , Visual pursuit exercises , Passive soft tissue stretching , Lower limb resistance exercises , Balance board training , Movement transitions.

Experimental Group A received Vestibular Stimulation along with Conventional therapy.

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants with age limit of 6-12 years
• Diagnosed cases of Spastic Diplegic Cerebral Palsy by Pediatric neurologist
• Both genders (male/female)
• Participants with GMFCS Level I-III
• Participants with Grade I spasticity, Modified Ashworth Scale (MAS) • Participants able to understand and follow basic commands.

You may not qualify if:

• Children with history of vestibular disorders, epileptic fits or uncontrolled seizures from past six months
• Children with any surgical procedure of the spine or lower limbs or Botox treatment in the last 6 months
• Children with any visual or hearing impairment
• Children having any fixed deformity, contracture or fracture limiting participation in therapy
• Patients having VP shunt

Sponsors & Collaborators

• Ibadat International University, Islamabad: lead

Study Sites (1)

Ibadat International University, Islamabad

Mansehra, KPK, 25000, Pakistan

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous 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: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: January 11, 2026
• Primary Completion: June 30, 2026
• Study Completion: July 3, 2026
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)