Cerebral PalsyNCT05540990
Robot Assisted Gait Training In Children With Cerebral Palsy
A study testing Robot assisted gait training and Conventional physiotherapy in people with Cerebral Palsy and Physical Therapy, run by Ankara University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Cerebral Palsy, Physical Therapy, Robotic Rehabilitation
- What is being tested?
- Robot assisted gait training and Conventional physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2022to 26 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Robot Assisted Gait Training In Children With Cerebral Palsy: Randomized Comparative Trial
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.
Read the 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).
- Being tested
- Robot assisted gait training, Conventional physiotherapy
- Keywords
- Cerebral Palsy, Robot assisted gait training, Gait
- Medical subject headings
- Cerebral Palsy, Motor Skills Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted gait trainingDevice
15 sessions of robot-assisted gait training (two times per week with a maximum of 45 minute each).
Conventional physiotherapyOther
individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group | Experimental | This group will receive 15 sessions of robot-assisted gait training (two or three times per week with a maximum of 45 minutes each) and conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week. Receives: Device: Robot assisted gait training; Other: Conventional physiotherapy |
| Conventional physiotherapy (CPt) group | Active comparator | This group will receive conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week. Receives: Other: Conventional physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 8 weeks, 14 weeks and 20 weeks
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.
Measured: baseline, 8 weeks, 14 weeks and 20 weeks
Secondary outcomes (5)
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.
Measured: baseline, 8 weeks, 14 weeks and 20 weeks
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.
Measured: baseline, 8 weeks, 14 weeks and 20 weeks
Change in Modified Ashworth Scale
The modified Ashworth scale is the most universally accepted clinical tool used to measure the increase of muscle tone.
Measured: baseline, 8 weeks, 14 weeks and 20 weeks
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.
Measured: baseline, 8 weeks, 14 weeks and 20 weeks
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).
Measured: baseline, 8 weeks, 14 weeks and 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start15 Sep 2022
- Primary completion26 Jul 2023
- Study completion26 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Birkan Sonel Tur, Ankara University
- Investigators
- Birkan Sonel Tur, Prof, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540990
- Sponsor's protocol ID
- İ5-310-21
- Status last verified
- Feb 2024
- First submitted
- 2 Sep 2022
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Robot Assisted Gait Training In Children With Cerebral Palsy: Randomized Comparative Trial
- ClinicalTrials.gov ID
- NCT05540990
- Acronym / sponsor ID
- İ5-310-21
- Keywords
- Cerebral Palsy, Robot assisted gait training, Gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 26 Jul 2023 (actual)
- Study completion
- 26 Jul 2023 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group | Experimental | Device: Robot assisted gait training, Other: Conventional physiotherapyThis group will receive 15 sessions of robot-assisted gait training (two or three times per week with a maximum of 45 minutes each) and conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week. |
| Conventional physiotherapy (CPt) group | Active comparator | Other: Conventional physiotherapyThis group will receive conventional physiotherapy, which is individually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot assisted gait training15 sessions of robot-assisted gait training (two times per week with a maximum of 45 minute each). | Device | Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group |
| Conventional physiotherapyindividually customized to the needs of the child and usually consists of 2-3 sessions of physiotherapy per week. | Other | Conventional physiotherapy (CPt) group, Robotic assisted gait training (RAGT) + conventional physiotherapy (CPt) group |
Primary outcome
Change in GMFM-88 D Item
Time frame: baseline, 8 weeks, 14 weeks and 20 weeks
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.
Change in GMFM-88 E Item
Time frame: baseline, 8 weeks, 14 weeks and 20 weeks
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.
5 secondary outcomes
Change in 6 Minute Walk Test
Time frame: baseline, 8 weeks, 14 weeks and 20 weeks
Change in 10 Meter Walk Test
Time frame: baseline, 8 weeks, 14 weeks and 20 weeks
Change in Modified Ashworth Scale
Time frame: baseline, 8 weeks, 14 weeks and 20 weeks
Change in Goal Attainment Scale (GAS)
Time frame: baseline, 8 weeks, 14 weeks and 20 weeks
Change in Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy Module (Parent Form)
Time frame: baseline, 8 weeks, 14 weeks and 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Birkan Sonel Tur, Prof principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted gait training and Conventional physiotherapy in people with Cerebral Palsy and Physical Therapy, run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in GMFM-88 D Item (time frame: baseline, 8 weeks, 14 weeks and 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.