NCT07595744

Brief Summary

This study aims to evaluate the effect of sensory walkway training on gait performance in children with spastic diplegic cerebral palsy. Participants will be assigned to a control group receiving conventional physical therapy or an intervention group receiving conventional therapy combined with sensory walkway training. The intervention will be conducted over a defined treatment period.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
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

Study Progress25%
Mar 2026Jan 2027

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2027

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

10 months

First QC Date

May 8, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

Sensory WalkwaySpastic DiplegicCerebral PalsyGait Parameters

Outcome Measures

Primary Outcomes (1)

  • Gait Speed

    Gait speed (m/s) will be assessed using the 10-Meter Walk Test (10MWT). Participants will walk a 10-meter distance at a self-selected comfortable walking speed. Time recorded during the test will be used only to calculate gait speed.

    3 months

Secondary Outcomes (3)

  • Step Width

    3 months

  • Cadence

    3 months

  • Step Time

    3 months

Study Arms (2)

Control Group - Conventional Physical Therapy

ACTIVE COMPARATOR

Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training. The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices. Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.

Behavioral: Conventional Physical Therapy Program

Study Group - Conventional Physical Therapy plus Sensory Walkway Training

EXPERIMENTAL

Participants in the study group will receive conventional physical therapy including stretching, strengthening, balance exercises, and gait training. In addition, they will undergo gait training on a sensory walkway consisting of wooden foot boxes filled with different textured materials to provide tactile stimulation. Corresponding hand sensory boxes are placed along parallel bars to provide simultaneous upper limb sensory input. Children will walk through the walkway while immersing their feet and hands in the textured materials and are encouraged to identify and describe textures to enhance sensory awareness. The intervention aims to improve sensory-motor integration, postural control, balance, and gait parameters in children with spastic diplegic cerebral palsy. Each session lasts 60 minutes and is performed three times per week for three months.

Behavioral: Conventional Physical Therapy ProgramBehavioral: Sensory Walkway Training

Interventions

Participants in the control group will receive a conventional physical therapy program including stretching exercises for lower limb muscles, strengthening exercises, balance training, and gait training. The program includes quadruped exercises, kneeling and half-kneeling positions, standing balance exercises using balance boards and beams, stepping exercises, and walking training using parallel bars and assistive devices. Each session lasts 60 minutes and will be conducted three times per week for three consecutive months.

Control Group - Conventional Physical TherapyStudy Group - Conventional Physical Therapy plus Sensory Walkway Training

Participants in the study group will receive conventional physical therapy in addition to gait training on a sensory walkway. The sensory walkway consists of a sequence of wooden foot boxes filled with different textured materials to provide tactile stimulation of the feet during walking. Corresponding hand sensory boxes are placed along parallel bars to provide simultaneous upper limb sensory input. This setup enables reciprocal sensory stimulation of upper and lower limbs during gait training. Children will walk through the walkway in a controlled manner while immersing their feet and hands in the textured materials and are encouraged to identify and describe the textures to enhance sensory awareness. The intervention aims to improve sensory-motor integration, postural control, balance, and gait parameters in children with spastic diplegic cerebral palsy. Each session lasts 60 minutes and is performed three times per week for three months.

Study Group - Conventional Physical Therapy plus Sensory Walkway Training

Eligibility Criteria

Age5 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Clinical diagnosis of spastic diplegic cerebral palsy
  • Aged between 5 and 7 years
  • Classified at level II on the Gross Motor Function Classification System
  • Spasticity grade 1 or 1+ according to the Modified Ashworth Scale
  • Able to walk independently or with an assistive device without physical assistance
  • Able to follow verbal commands
  • Abnormal gait pattern

You may not qualify if:

  • Visual or auditory impairment
  • History of lower limb surgery within the past 2 years
  • Use of medications affecting muscle tone and/or cognitive function
  • Contractures or fixed deformities in upper or lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic, Faculty of Physical Therapy, Cairo University

Dokki, Giza Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Shaymaa Rushdy Mahmoud, lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned into two parallel groups: a control group receiving a conventional physical therapy program and a study group receiving the same program in addition to sensory walkway training.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
B.Sc. Physical Therapy

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 19, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 31, 2027

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect participants' privacy and confidentiality. The data collected in this study will be used for research purposes only and will not be publicly available.

Locations