Clinical trial NCT05540990: Robot Assisted Gait Training In Children With Cerebral Palsy
Official title: The Effectiveness of Robot Assisted Gait Training In Children With Cerebral Palsy: Randomized Comparative Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Physical Therapy
Robotic Rehabilitation
Motor Skills Disorders
Keywords: Cerebral Palsy, Robot assisted gait training, Gait
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2022-09-15
Enrollment: 57
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in GMFM-88 D Item
timeFrame: baseline, 8 weeks, 14 weeks and 20 weeks
measure: Change in GMFM-88 E Item
timeFrame: baseline, 8 weeks, 14 weeks and 20 weeks
Secondary outcomes:
measure: Change in 6 Minute Walk Test
timeFrame: baseline, 8 weeks, 14 weeks and 20 weeks
measure: Change in 10 Meter Walk Test
timeFrame: baseline, 8 weeks, 14 weeks and 20 weeks
measure: Change in Modified Ashworth Scale
timeFrame: baseline, 8 weeks, 14 weeks and 20 weeks
measure: Change in Goal Attainment Scale (GAS)
timeFrame: baseline, 8 weeks, 14 weeks and 20 weeks
measure: Change in Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module (Parent Form)
timeFrame: baseline, 8 weeks, 14 weeks and 20 weeks
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University
Study officials:
affiliation: Ankara University
name: Birkan Sonel Tur, Prof
role: PRINCIPAL_INVESTIGATOR
References: