Robot Assisted Gait Training In Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05540990
• Other study ID #: I5-310-21
• Status: Completed
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: July 26, 2023

Study information

• Verified date: February 2024
• Source: Ankara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 26, 2023
• Est. primary completion date: July 26, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Motor Skills Disorders
• Paralysis
• Physical Therapy
• Robotic Rehabilitation

Intervention

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

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

Locations

Country	Name	City	State
Turkey	Ankara University	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in 6 Minute Walk Test	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.	baseline, 8 weeks, 14 weeks and 20 weeks
Secondary	Change in 10 Meter Walk Test	The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance.	baseline, 8 weeks, 14 weeks and 20 weeks
Secondary	Change in Modified Ashworth Scale	The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.	baseline, 8 weeks, 14 weeks and 20 weeks
Secondary	Change in Goal Attainment Scale (GAS)	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.	baseline, 8 weeks, 14 weeks and 20 weeks
Secondary	Change in Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module (Parent Form)	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).	baseline, 8 weeks, 14 weeks and 20 weeks