Robot Assisted Gait Training In Children With Cerebral Palsy

NCT05540990 | Completed

• 1 other identifier: İ5-310-21
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral Palsy (CP) is considered a neurological disorder caused by a non-progressive brain injury or malformation that occurs while the child's brain is under development. CP primarily affects body movement and muscle coordination. Robot assisted gait training (RAGT) is considered to be a promising approach for improving gait related gross motor function of children and youth with CP. There is weak and inconsistent evidence regarding the use of RAGT for children with gait disorders. Further research is required with increased numbers and with relevant outcome measures to both confirm the effectiveness and clarify training schedules. The aim of this research project is to investigate the effectiveness of robot assisted gait training on improvements of functional gait parameters in children with cerebral palsy.

Conditions

Cerebral Palsy; Physical Therapy; Robotic Rehabilitation; Motor Skills Disorders

Keywords

Cerebral Palsy, Robot assisted gait training, Gait

Outcome Measures

Primary Outcomes (2)

• Change in GMFM-88 D Item

  The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. D dimension is for Standing abilities. The score of each dimension is expressed as a percentage of the maximum score. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. It takes between 20-25 minutes to be completed.

  baseline, 8 weeks, 14 weeks and 20 weeks

• Change in GMFM-88 E Item

  The Gross Motor Function Measure (GMFM) is an assessment tool designed and evaluated to measure changes in gross motor function over time or with intervention in children with cerebral palsy. GMFM-88 is a measure developed to evaluate the gross motor function changes in CP children. It has five components: lying and rolling, sitting, kneeling and crawling, standing, and walking. E dimension is for Walking, Running \& Jumping abilities. The score of each dimension is expressed as a percentage of the maximum score. There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed, is used. It takes between 20-25 minutes to be completed.

  baseline, 8 weeks, 14 weeks and 20 weeks

Secondary Outcomes (5)

• Change in 6 Minute Walk Test

  baseline, 8 weeks, 14 weeks and 20 weeks

• Change in 10 Meter Walk Test

  baseline, 8 weeks, 14 weeks and 20 weeks

• Change in Modified Ashworth Scale

  baseline, 8 weeks, 14 weeks and 20 weeks

• Change in Goal Attainment Scale (GAS)

  baseline, 8 weeks, 14 weeks and 20 weeks

• Change in Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module (Parent Form)

  baseline, 8 weeks, 14 weeks and 20 weeks

Study Arms (2)

Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group

EXPERIMENTAL

This group will receive 15 sessions of robot-assisted gait training (two or three times per week with a maximum of 45 minutes each) and conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Device: Robot assisted gait training; Other: Conventional physiotherapy

Conventional physiotherapy (CPt) group

ACTIVE COMPARATOR

This group will receive conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Other: Conventional physiotherapy

Interventions

Robot assisted gait training DEVICE

15 sessions of robot-assisted gait training (two times per week with a maximum of 45 minute each).

Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group

Conventional physiotherapy OTHER

individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.

Conventional physiotherapy (CPt) group; Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• GMFCS Level 2-4
• Bilateral or unilateral spastic CP
• Able to follow instructions and communicate pain or discomfort
• Have a passive range of motion (ROM) of hips and knees within minimum range requirement for robotic assisted training (hip and knee flexion contracture ≤10°, and knee valgus ≤40°)
• Not having participated in another robotic assisted training regime within the previous 6 months
• Able to participate in a minimum of 30 minutes robotic assisted training session
• Able to commit to attendance of two to three times weekly for 15 sessions (to support the primary efficacy analysis)

You may not qualify if:

• Botulinum toxin type A injection within 3 months
• Orthopedic surgery on the lower extremity (muscle surgery within the last 9 months, bone surgery within 12 months)
• Bone fractures, open skin lesions, or circulatory problems
• Vision and hearing impairments that affect participation in robotic assisted training
• Epilepsy resistant to medication
• Cardiopulmonary instability
• Use of a baclofen pump

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University

Ankara, 06530, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy; Motor Skills Disorders

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Birkan Sonel Tur, Prof

  Ankara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 15, 2022
• Study Start: September 15, 2022
• Primary Completion: July 26, 2023
• Study Completion: July 26, 2023
• Last Updated: February 8, 2024

Record last verified: 2024-02

Locations

TU (1)