Cerebral PalsyNCT06403891
The Effect of a Comprehensive Rehabilitation Program Using Robotic Walking and Functional Electrical Stimulation Technologies on Balance and Walking in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the effect of a comprehensive rehabilitation program using robotic walking and functional electrical stimulation technologies on balance and gait in children with cerebral palsy. This study was planned as a prospective observational study. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 15 May 2024
- Phase
- Observational
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients between the ages of 2-18, diagnosed with cerebral palsy, receiving inpatient treatment in Ankara Bilkent City Hospital
Who may be able to join
- Being between the ages of 2-18
- Being diagnosed with cerebral palsy
- Walking independently with or without an assistive walking device
- Having a GMFCS score between 1-3
- Lack of seizure history
- Showing consent to participate in the study (signing the informed consent by the legal guardian of the patient)
Who cannot join
- Presence of contracture in lower extremities
- Being administered botulinum toxin within the last one month before treatment or during the 6-week treatment period
- Being unable to cooperate with clinical assessments
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
Berat M Alkan, Professor, +90 312 552 60 00, beratalkan73@gmail.com
About this study
The aim of this study was to investigate the effect of a comprehensive rehabilitation program using robotic walking and functional electrical stimulation technologies on balance and gait in children with cerebral palsy. This study was planned as a prospective observational study. A total of 30 patients in two groups were planned to be included in the study. Patients in both groups were planned to receive a 6-week conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. The case group was planned to consist of patients who received a comprehensive rehabilitation program using high-tech devices including functional electrical stimulation (FES) and robotic rehabilitation applications in addition to the conventional rehabilitation program.
- Conditions
- Cerebral Palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | The control group was planned to consist of patients who received a 6-week conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. | |
| Case | The case group was planned to consist of patients who received a comprehensive rehabilitation program using high-tech devices including functional electrical stimulation (FES) and robotic rehabilitation applications in addition to the conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cadence
The number of steps taken per minute
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Step length
The distance between the initial contact of one foot and the initial contact of the contralateral foot
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Stride length
The distance between the consecutive initial contacts of the same foot
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Track width
The mediolateral distance between right and left heels during gait
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Range of motion of joints during the gait cycle
Range of motion of the knee, hip and ankle joint during the gait cycle
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Range of motion of the pelvis in the frontal plane during the gait cycle
Range of motion of the pelvis in the frontal plane during the gait cycle
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Plantar surface pressure distribution
Plantar surface pressure distribution measured by pedobarograph
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Secondary outcomes (3)
Spasticity
Spasticity will be assessed with the Modified Ashworth Scale
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Balance
Balance will be assessed with the Pediatric Berg Balance Scale
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Gait speed
Gait speed will be assessed with the 10-meter walk test
Measured: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start15 Mar 2022
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT06403891
- Sponsor's protocol ID
- E2-22-1398
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 8 May 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 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Comprehensive Rehabilitation Program Using Robotic Walking and Functional Electrical Stimulation Technologies on Balance and Walking in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06403891
- Acronym / sponsor ID
- E2-22-1398
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 8 May 2024 (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 aim of this study was to investigate the effect of a comprehensive rehabilitation program using robotic walking and functional electrical stimulation technologies on balance and gait in children with cerebral palsy. This study was planned as a prospective observational study. A total of 30 patients in two groups were planned to be included in the study. Patients in both groups were planned to receive a 6-week conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. The case group was planned to consist of patients who received a comprehensive rehabilitation program using high-tech devices including functional electrical stimulation (FES) and robotic rehabilitation applications in addition to the conventional rehabilitation program.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –The control group was planned to consist of patients who received a 6-week conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. |
| Case | – | –The case group was planned to consist of patients who received a comprehensive rehabilitation program using high-tech devices including functional electrical stimulation (FES) and robotic rehabilitation applications in addition to the conventional rehabilitation program that was prepared to meet the requirements of their clinical conditions, including neurophysiological exercises, balance-coordination and posture exercises. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients between the ages of 2-18, diagnosed with cerebral palsy, receiving inpatient treatment in Ankara Bilkent City Hospital
Key inclusion criteria (6 listed)
- Being between the ages of 2-18
- Being diagnosed with cerebral palsy
- Walking independently with or without an assistive walking device
- Having a GMFCS score between 1-3
- Lack of seizure history
Key exclusion criteria (3 listed)
- Presence of contracture in lower extremities
- Being administered botulinum toxin within the last one month before treatment or during the 6-week treatment period
- Being unable to cooperate with clinical assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cadence
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
The number of steps taken per minute
Step length
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
The distance between the initial contact of one foot and the initial contact of the contralateral foot
Stride length
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
The distance between the consecutive initial contacts of the same foot
Track width
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
The mediolateral distance between right and left heels during gait
Range of motion of joints during the gait cycle
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Range of motion of the knee, hip and ankle joint during the gait cycle
Range of motion of the pelvis in the frontal plane during the gait cycle
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Range of motion of the pelvis in the frontal plane during the gait cycle
Plantar surface pressure distribution
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Plantar surface pressure distribution measured by pedobarograph
3 secondary outcomes
Spasticity
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Balance
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Gait speed
Time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
Related trials for Cerebral Palsy
Not yet recruitingObservational study
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
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?
An observational study of Cerebral Palsy, 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 3 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 8 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berat M Alkan, Professor (+90 312 552 60 00, beratalkan73@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cadence (time frame: The first assessment was planned before the rehabilitation program, and the second assessment was planned at the end of the 6-week rehabilitation program). The study lists 7 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 May 2024.