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

NCT ID: NCT04781101

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-15
• Study Completion Date: 2020-01-15

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

conventional therapy

conventional therapy

Group Type: EXPERIMENTAL

conventional therapy

Intervention Type: OTHER

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.

RoboGait®

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).

Group Type: EXPERIMENTAL

RoboGait®

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• diplegic CP and who were level 2-5 according to the Gross Motor Function Classification System (GMFCS) were included in the study. Children who presented with any disorder involving the peripheral nervous system or another neurological disorder such as epilepsy were not included.

Exclusion Criteria

• Patients in whom the dose of their prescribed medication for spasticity was changed during the study period were excluded

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Okan University

OTHER

Sponsor Role: lead

Responsible Party

Emine Atıcı

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tülay Çevik Saldıran, PhD

Role: STUDY_CHAIR

Bitlis Eren University

Locations

Okan University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

13.02.2019-103

Identifier Type: -

Identifier Source: org_study_id