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NCT Number: NCT05540990

Robot Assisted Gait Training In Children With Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Mental Disorders Motor Skills Disorders Nervous System Diseases Neurodevelopmental Disorders Physical Therapy Robotic Rehabilitation

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara University

Ankara, 06530, Turkey (Türkiye)

About this study

Cerebral Palsy (CP) is a disorder of posture and movement due to a defect in the immature brain. There is evidence that locomotor therapy for regaining walking capacity using the principle of enhancing neuroplasticity by task-specific training is effective in the rehabilitation process of patients with central gait disorders. The use of a robotic device assists in achieving and maintaining physiological walking pattern for extended periods of therapy. The use of robotic devices as an alternative treatment to improve the gait function in patients with CP has increased.

This is a prospective, randomized comparative trial (RCT). This study is designed to compare the effectiveness of conventional physical therapy (CPt) and robot assisted gait training (RAGT) on gait related motor skills of children with cerebral palsy.

Children aged 5 to 18 years with GMFCS Level 2-4, bilateral or unilateral spastic CP are accepted into this study. Participants are randomly assigned to receive CPt or RAGT + CPt.

All two intervention groups will receive 2-3 sessions of CPt per week over 6-8 weeks. CPt sessions are individually customized to the needs of the child.

The participants of RAGT + CPt group also receive 15 sessions of RAGT (2-3 times per week with a maximum of 45 minute each).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Robot assisted gait training

Device

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

Conventional Physiotherapy

Other

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

Primary outcomes

  1. Change in GMFM-88 D Item

    Time frame: baseline, 8 weeks, 14 weeks and 20 weeks

    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.

  2. Change in GMFM-88 E Item

    Time frame: baseline, 8 weeks, 14 weeks and 20 weeks

    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.

Secondary outcomes

  1. Change in 6 Minute Walk Test

    Time frame: baseline, 8 weeks, 14 weeks and 20 weeks

    The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.

  2. Change in 10 Meter Walk Test

    Time frame: baseline, 8 weeks, 14 weeks and 20 weeks

    The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.

  3. Change in Modified Ashworth Scale

    Time frame: baseline, 8 weeks, 14 weeks and 20 weeks

    The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.

  4. Change in Goal Attainment Scale (GAS)

    Time frame: baseline, 8 weeks, 14 weeks and 20 weeks

    The GAS methodology is congruent with the client-centered occupational therapy philosophy because GAS provides a means to identify intervention outcomes that are specifically relevant to individuals and their families.

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

    Time frame: baseline, 8 weeks, 14 weeks and 20 weeks

    The PedsQL 3.0 CP module is questionnaire designed to assess the quality of life in children with cerebral palsy. The 35-item PedsQL 3.0 CP Module encompasses seven scales: (1) Daily Activities (9 items); (2) School Activities (4items); (3) Movement and Balance (5 items); (4) Pain andHurt (4 items); (5) Fatigue (4 items); (6) Eating Activities (5items); and (7) Speech and Communication (4 items). A 5-point response scale is utilized across child self-report for ages 8 to 18 years and parent proxy-report (0=never a problem; 1=almost never a problem;2=sometimes a problem; 3=often a problem; 4=almostalways a problem).

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Registry information

Official study title

The Effectiveness of Robot Assisted Gait Training In Children With Cerebral Palsy: Randomized Comparative Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 15, 2022
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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