Cerebral PalsyNCT05883488
Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy
A study testing Robot-assisted upper extremity rehabilitation and Conventional rehabilitation in people with Cerebral Palsy and Upper Extremity Problem, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The use of robotic rehabilitation, a treatment method for improving the motor functions of the upper extremities, is gradually increasing in children with cerebral palsy. The aim of this study is to investigate the effect of robot-assisted rehabilitation for the upper extremity on upper extremity functions, manual… Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Cerebral Palsy, Upper Extremity Problem
- What is being tested?
- Robot-assisted upper extremity rehabilitation and Conventional rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Jul 2023to 15 Nov 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy
- Be between the ages of 5-15
- Levels I, II and III according to the Manual Ability Classification System (MACS)
- Have sufficient cognitive level, such as the ability to understand and follow simple instructions, and to perform desired tasks
- The upper extremity dimensions are suitable for the robot
- Parents and patients aged ≥ 9 years have agreed to participate in the study
Who cannot join
- Injection of antispasticity drugs (eg Botox) into upper extremity muscles and/or upper extremity orthopedic surgery in the last 6 months
- Having musculoskeletal disorders and peripheral nervous system disorders that impair the ability to use the upper extremity robotic system
- Having severe muscle spasticity and/or contracture
- Having uncontrolled seizures and/or presence of visually induced seizures
- Having severe learning difficulties, behavioral problems, skin lesions, visual and/or hearing difficulties that may affect function and participation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, Çankaya, 06800
Banuçiçek Türk, Doctor, +905362990238, banuciceku@gmail.com
About this study
The use of robotic rehabilitation, a treatment method for improving the motor functions of the upper extremities, is gradually increasing in children with cerebral palsy.
The aim of this study is to investigate the effect of robot-assisted rehabilitation for the upper extremity on upper extremity functions, manual skills and quality of life in patients with unilateral or bilateral/triplegic spastic cerebral palsy and also to compare the effect of robot-assisted upper extremity rehabilitation compared to traditional rehabilitation methods.
Read the detailed description
In this study, it was planned to include 42 patients diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy, aged 5-15 years, who were treated in the Pediatric Rehabilitation Service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and met the inclusion criteria.
Participants will be divided into two groups as study and control groups. In addition to the conventional rehabilitation program, the study group will be included in the robot-assisted upper extremity rehabilitation program, while the control group will be included in the conventional rehabilitation program only.
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes. The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment. Assessments will be made before initiating treatment, at the end of treatment, and 3 months after initiation of treatment.
- Conditions
- Cerebral Palsy, Upper Extremity Problem
- Being tested
- Robot-assisted upper extremity rehabilitation, Conventional rehabilitation
- Keywords
- Cerebral Palsy, Robotic rehabilitation, Upper extremity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-assisted upper extremity rehabilitationOther
The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment.
Conventional rehabilitationOther
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Robotic rehabilitation group | Experimental | The robotic rehabilitation group will receive a robot-assisted upper extremity rehabilitation program in addition to the conventional rehabilitation program.The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes. Receives: Other: Robot-assisted upper extremity rehabilitation; Other: Conventional rehabilitation |
| Conventional rehabilitation group | Active comparator | Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
QUEST (Quality of Upper Extremity Skills Test)
It is a test developed to measure upper extremity functions. It consists of 7 sub-headings including dissociated movements, grasping, weight bearing, protective extension, hand function rating, spasticity rating and cooperativeness rating.
Measured: Change from baseline Quality of upper extremity skills test at 4 weeks and 3 months
Secondary outcomes (4)
ABILHAND-Kids
It is a functional scale developed to measure manual abilities. It measures the child's manual ability during daily activities and parents are asked to evaluate during these activities. The test consists of 21 questions and parents answer the questions in the test as impossible, difficult or easy. It is scored as impossible: 0, difficult: 1, easy: 2. The maximum score in the test is 42 and the minimum score is 0. Higher scores indicate better manual ability.
Measured: Change from baseline ABILHAND-Kids at 4 weeks and 3 months
Box and Block Test
It is a time-based test that evaluates rough manual dexterity. The participant is asked to throw the cubes on one side of a wooden box divided into two into the other compartment, and the result is obtained by counting how many cubes he has thrown in 60 seconds.
Measured: Change from baseline Box and Block Test at 4 weeks and 3 months
KINDL (Questionnaire to assess Health-Related Quality of Life in children and adolescents)
It is a questionnaire that measures the quality of life in children and adolescents, and there are child and family forms for different age groups. In this study, KINDL 3-6 age family form and 7-17 age family form will be used. KINDL 3-6 age family form is a questionnaire consisting of 52 questions in total about physical well-being, emotional well-being, self-esteem, family, social relations, kindergarten/nursery, other questions and illness. KINDL 7-17 age family form is a questionnaire consisting of 30 questions in total about physical well-being, emotional well-being, self-esteem, family, social relations, school, and illness. Parents answer questions as never, rarely, sometimes, often, or always. Questions are scored from 1 to 5. Negative questions are scored by reversing. Each section is scored between 0-100. A higher score indicates a higher quality of life.
Measured: Change from baseline KINDL at 4 weeks and 3 months
Modified Ashworth Scala (MAS)
It is used to evaluate the severity of spasticity. The joint is moved passively throughout the range of motion and the felt resistance is evaluated. In this study, shoulder adductors, elbow flexors, wrist flexors, and finger flexors will be evaluated with MAS. Spasticity severity is evaluated in 4 degrees. (0: no increase in muscle tone, 4: affected parts are rigid in flexion and extension). Higher scores indicate greater spasticity severity.
Measured: Change from baseline Modified Ashworth Scala at 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start19 Jul 2023
- Primary completion15 Nov 2023 (estimated)
- Study completion15 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883488
- Sponsor's protocol ID
- AnkaraCHBilkent-BT
- Status last verified
- May 2023
- First submitted
- 13 Mar 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen YP, Howard AM. Effects of robotic therapy on upper-extremity function in children with cerebral palsy: A systematic review. Dev Neurorehabil. 2016;19(1):64-71. doi: 10.3109/17518423.2014.899648. Epub 2014 Apr 11.
PubMed 24724587Fasoli SE, Ladenheim B, Mast J, Krebs HI. New horizons for robot-assisted therapy in pediatrics. Am J Phys Med Rehabil. 2012 Nov;91(11 Suppl 3):S280-9. doi: 10.1097/PHM.0b013e31826bcff4.
PubMed 23080043
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Robot-Assisted Upper Extremity Rehabilitation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05883488
- Acronym / sponsor ID
- AnkaraCHBilkent-BT
- Conditions
- Cerebral Palsy, Upper Extremity Problem
- Keywords
- Cerebral Palsy, Robotic rehabilitation, Upper extremity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 19 Jul 2023 (actual)
- Primary completion
- 15 Nov 2023 (estimated)
- Study completion
- 15 Nov 2023 (estimated)
- First posted
- 1 Jun 2023 (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.
The use of robotic rehabilitation, a treatment method for improving the motor functions of the upper extremities, is gradually increasing in children with cerebral palsy.
The aim of this study is to investigate the effect of robot-assisted rehabilitation for the upper extremity on upper extremity functions, manual skills and quality of life in patients with unilateral or bilateral/triplegic spastic cerebral palsy and also to compare the effect of robot-assisted upper extremity rehabilitation compared to traditional rehabilitation methods.
Detailed description
In this study, it was planned to include 42 patients diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy, aged 5-15 years, who were treated in the Pediatric Rehabilitation Service of Ankara City Hospital Physical Therapy and Rehabilitation Hospital, and met the inclusion criteria.
Participants will be divided into two groups as study and control groups. In addition to the conventional rehabilitation program, the study group will be included in the robot-assisted upper extremity rehabilitation program, while the control group will be included in the conventional rehabilitation program only.
Conventional rehabilitation program will be applied 5 days a week, lasting 60 minutes. The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment. Assessments will be made before initiating treatment, at the end of treatment, and 3 months after initiation of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic rehabilitation group | Experimental | Other: Robot-assisted upper extremity rehabilitation, Other: Conventional rehabilitationThe robotic rehabilitation group will receive a robot-assisted upper extremity rehabilitation program in addition to the conventional rehabilitation program.The robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes. |
| Conventional rehabilitation group | Active comparator | Other: Conventional rehabilitationConventional rehabilitation program will be applied 5 days a week, lasting 60 minutes. |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Being diagnosed with unilateral or bilateral/triplegic spastic cerebral palsy
- Be between the ages of 5-15
- Levels I, II and III according to the Manual Ability Classification System (MACS)
- Have sufficient cognitive level, such as the ability to understand and follow simple instructions, and to perform desired tasks
- The upper extremity dimensions are suitable for the robot
Key exclusion criteria (5 listed)
- Injection of antispasticity drugs (eg Botox) into upper extremity muscles and/or upper extremity orthopedic surgery in the last 6 months
- Having musculoskeletal disorders and peripheral nervous system disorders that impair the ability to use the upper extremity robotic system
- Having severe muscle spasticity and/or contracture
- Having uncontrolled seizures and/or presence of visually induced seizures
- Having severe learning difficulties, behavioral problems, skin lesions, visual and/or hearing difficulties that may affect function and participation
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 upper extremity rehabilitationThe robotic rehabilitation program (with the Armeo Spring Pediatric Robotic Rehabilitation system) will be implemented 3 days a week for 30 minutes in addition to the conventional rehabilitation program. Participants will receive a total of 4 weeks of treatment. | Other | Robotic rehabilitation group |
| Conventional rehabilitationConventional rehabilitation program will be applied 5 days a week, lasting 60 minutes. | Other | Conventional rehabilitation group, Robotic rehabilitation group |
Primary outcome
QUEST (Quality of Upper Extremity Skills Test)
Time frame: Change from baseline Quality of upper extremity skills test at 4 weeks and 3 months
It is a test developed to measure upper extremity functions. It consists of 7 sub-headings including dissociated movements, grasping, weight bearing, protective extension, hand function rating, spasticity rating and cooperativeness rating.
4 secondary outcomes
ABILHAND-Kids
Time frame: Change from baseline ABILHAND-Kids at 4 weeks and 3 months
Box and Block Test
Time frame: Change from baseline Box and Block Test at 4 weeks and 3 months
KINDL (Questionnaire to assess Health-Related Quality of Life in children and adolescents)
Time frame: Change from baseline KINDL at 4 weeks and 3 months
Modified Ashworth Scala (MAS)
Time frame: Change from baseline Modified Ashworth Scala at 4 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 24724587Chen YP, Howard AM. Effects of robotic therapy on upper-extremity function in children with cerebral palsy: A systematic review. Dev Neurorehabil. 2016;19(1):64-71. doi: 10.3109/17518423.2014.899648. Epub 2014 Apr 11.
- Background: PubMed 23080043Fasoli SE, Ladenheim B, Mast J, Krebs HI. New horizons for robot-assisted therapy in pediatrics. Am J Phys Med Rehabil. 2012 Nov;91(11 Suppl 3):S280-9. doi: 10.1097/PHM.0b013e31826bcff4.
Related trials for Cerebral Palsy
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Active, not recruiting
Functional Outcomes and Control Using Synchron BCI - Australia
Neurologic Disorder, Neurologic Diseases
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
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.
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 upper extremity rehabilitation and Conventional rehabilitation in people with Cerebral Palsy and Upper Extremity Problem, run by Ankara City Hospital Bilkent 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Banuçiçek Türk (0536 299 02 38, banuciceku@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QUEST (Quality of Upper Extremity Skills Test) (time frame: Change from baseline Quality of upper extremity skills test at 4 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05883488, which also lists 2 linked publications.
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 28 Sep 2023.