Clinical trial NCT04781101: Can Robot-Assisted Gait Training In Addition To Conventional Rehabilitation Provide Better Outcomes In Children With Cerebral Palsy?
Official title: 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Robotics
Keywords: Cerebral palsy
Robotics
Functional status
Lead sponsor: Okan University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: GMFCS
timeFrame: 5 minute
measure: TUG test
timeFrame: 10 minute
measure: WeeFIM
timeFrame: 20 minute
measure: PBBS
timeFrame: 15 minute
measure: Modified Ashworth Scale (MAS).
timeFrame: 15 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Okan University
Study officials:
affiliation: Bitlis Eren University
name: Tülay Çevik Saldıran, PhD
role: STUDY_CHAIR
References: