NCT04781101

Can Robot-Assisted Gait Training In Addition To Conventional Rehabilitation Provide Better Outcomes In Children With Cerebral Palsy?

Can Robot-Assisted Gait Training In Addition To Conventional Rehabilitation Provide Better Outcomes In Terms Of Balance, Spasticity And Functionality In Children With Cerebral Palsy?

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Okan University · Academic / Other
• Sex: All
• Age: 7 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

A total of 26 patients who were diagnosed with CP \[diplegic, with Gross Motor Function Classification System (GMFCS) level of 2-5\] and who regularly participated in a rehabilitation programme were included in the study after obtaining approval from their parents. The patients were randomly assigned to two groups. Group 1 (n = 13) received conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2 days/week ×8).

Detailed description

Purpose: This study aimed to investigate the effects of robot-assisted training (RAT) on motor functions, spasticity status, balance and functionality in children with cerebral palsy (CP). Method: A total of 26 patients who were diagnosed with CP \[diplegic, with Gross Motor Function Classification System (GMFCS) level of 2-5\] and who regularly participated in a rehabilitation programme were included in the study after obtaining approval from their parents. The patients were randomly assigned to two groups. Group 1 (n = 13) received conventional therapy (65 min, 2 days/week ×8) and group 2 (n = 13) received 25 minutes of robot-assisted gait training (RoboGait®) in addition to conventional therapy (40 min, 2 days/week ×8). Outcome measures: GMFCS was used to evaluate motor functions and Modified Ashworth Scale was used to evaluate spasticity. Paediatric Berg Balance Scale, Paediatric Functional Independence Measure and timed up and go test were used to assess balance and functional status. The evaluations were performed at baseline and after 8 weeks of therapy.

Conditions

• Cerebral Palsy
• Robotics

Interventions

Type	Name	Description
OTHER	conventional therapy	Conventional therapy sessions that were planned by a physiotherapist for the children were conducted by a physiotherapist experienced in paediatrics. The therapy sessions mainly focused on functions such as the regulation of muscle tone, correction of posture, elimination of stiffness, muscle strengthening, balance/coordination training and mobilisation (Figure 2). The sessions were planned to last 40 minutes.
OTHER	RoboGait®	The RoboGait®-assisted gait system was used for the robot-assisted gait training. In addition to conventional therapy, 16 robot-assisted gait training sessions were conducted, each lasting 25 minutes for 2 days a week (400 minutes in total). Gait speed was 1.5 km/h in all sessions. Considering conditions such as joint limitations and spasticity, gait training was performed with patients bearing 45% to 75% of their weight.

Timeline

• Start date: 2019-02-15
• Primary completion: 2019-04-15
• Completion: 2020-01-15
• First posted: 2021-03-04
• Last updated: 2021-03-04

Locations

1 site across 1 country: Turkey (Türkiye)