Cerebral PalsyAOT-CPNCT07247331
The Effect of Action Observation Therapy on Spasticity, Motor Function, and Balance in Children With Cerebral Palsy
An observational study of Cerebral Palsy and Spastic Diplegia Cerebral Palsy, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
In our randomized controlled study, which aims to investigate the contribution of Action Observation Therapy to rehabilitation by examining the effect of Action Observation Therapy on spasticity, gross motor function, balance and participation in children with spastic diplegic and hemiplegic cerebral palsy, the… Read more about this study
- Who is it for?
- Ages 5 to 13 years
- Conditions the study is for
- Cerebral Palsy, Spastic Diplegia Cerebral Palsy, Hemiplegic Cerebral Palsy
- What is being tested?
- action observation therapy
- Type of treatment
- Pill or oral medicine
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Dec 2022to 7 Jul 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 5 to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: In order to prevent bias in terms of participants meeting the inclusion criteria, sociodemographic and clinical characteristics, criteria such as age, CP type, GMFCS level and presence of comorbidities were taken into account in assigning individuals to groups in the study, and the stratified randomization method will be used. Accordingly, the age ranges are taken as 5-7, 8-10, 11-13, and the CP type is; spastic diplegic and hemiplegic, GMFCS level; It will be taken as I-III and the stratification process will be done accordingly.
Who may be able to join
- 5-13 years old
- Diagnosis of spastic hemiplegic and diplegic cerebral palsy
- Gross Motor Function Classification System (GMFCS) Level I-III
- Consent to participate in the study
Who cannot join
- Spastic hemiplegic and diplegic disease not associated with cerebral palsy
- Presence of contractures affecting functional movement in the affected extremity
- Presence of cardiopulmonary disease or severe visual and hearing impairments
- Children who have had a seizure in the last 6 months
- Children who have had any surgery or received botulinum injections within the last 6 months or during the study period.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University
Isparta, Isparta, 32200
About this study
Official title: Effect of Action Observation Therapy on Spasticity, Gross Motor Function, Balance And Participation in Children With Cerebral Palsy: A Randomized Controlled Study
In our randomized controlled study, which aims to investigate the contribution of Action Observation Therapy to rehabilitation by examining the effect of Action Observation Therapy on spasticity, gross motor function, balance and participation in children with spastic diplegic and hemiplegic cerebral palsy, the effectiveness of Action Observation Therapy to be applied in the home environment and accompanied by a physiotherapist will be investigated.
Read the detailed description
In this study, G*Power 3.1.3 program was used to calculate the minimum sample size in each group (control group (group 1), group 2 and group 3), in other words, the number of individuals in the groups. In this context, the effect size was taken as d = 1.1, the significance level was α = 0.05, and the minimum number of individuals in each group was calculated as 11 (33 in total) for a power of 0.80 (80%). Similar studies (Sgandurra 2013, Kim 2018) were taken into consideration in obtaining these parameters. The number of individuals in each group (+10%) was planned to be at least 12 (36 in total), taking into account individuals who were missing, incorrect or excluded from the study.
In order to prevent bias in terms of participants meeting the inclusion criteria, sociodemographic and clinical characteristics, criteria such as age, cerebral palsy type, GMFCS level and presence of comorbidities were taken into account in assigning individuals to groups in the study, and the stratified randomization method will be used. Accordingly, the age ranges are taken as 5-7, 8-10, 11-13, and the cerebral palsy type is; spastic diplegic and hemiplegic, GMFCS level; It will be taken as I-III and the stratification process will be done accordingly. Before the study, written and verbal "Informed Consent Form" will be obtained from the parents of all participants in the study and control groups. The content of the study will be explained to the children who will participate in the study in a way that the child can understand, and the child's consent will be obtained. After recording the sociodemographic data of the participants for both the experimental and control groups, their spasticity was measured by the Modified Ashworth Scale (MAS), their gross motor function levels were measured by the Gross Motor Function Measurement (GMFM), their participation was measured by the Child and Adolescent Participation Survey (CASP), and their balance was measured by the Timed Up and Go Test ( TUG), Pediatric Reach Test (PRT) and Pediatric Balance Scale (PDS), and the extent to which the individual goal has been achieved will be evaluated by the Goal Attainment Scale (GAS). Assessments will be administered the day before starting treatment, after completing the 6-week Action Observation Therapy, and after a 3-month follow-up period.
Treatment Program of the Control Group (Group 1): This group will not be shown any video clips, and general physiotherapy methods will be applied to their current needs, 2 sessions a week for 6 weeks. This method includes stretching exercises for spastic muscles, strengthening exercises for the antagonist of the spastic muscle, and stabilization exercises.
Group 2: Action Observation Therapy for the lower extremities will be applied to this group by their parents at home, 2 sessions a week for 6 weeks. Participants will be shown a video of a task by their parents at home. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip.
Group 3: Action Observation Therapy for the lower extremities will be applied by the therapist to this group, 2 sessions a week for 6 weeks. Participants will watch a video of a task presented by a therapist. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip. After each session of Action Observation Therapy, 20 minutes of physiotherapy will be applied towards the goals of 6 activities. The scope of physiotherapy to be applied will consist of activity-based exercises for the lower extremities, stepping, weight transfer, balance and functionality.
- Being tested
- action observation therapy
- Medical subject headings
- Cerebral Palsy, Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
action observation therapyOther
Action Observation Therapy (AOT) is among the neurorehabilitation approaches that enable motor learning by facilitating neuroplasticity. AOT is based on neuroscience and activation of the mirror neuron system. AOT occurs in the form of the observer following the motor action and performing the observed actions after observing the actions. AOT aims to improve different motor functions by providing motor learning through neuroplasticity activation.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Program of the Control Group (Group 1): | Treatment Program of the Control Group (Group 1): This group will not be shown any video clips, and general physiotherapy methods will be applied to their current needs, 2 sessions a week for 6 weeks. This method includes stretching exercises for spastic muscles, strengthening exercises for the antagonist of the spastic muscle, and stabilization exercises. Receives: Other: action observation therapy | |
| Group 2 | Action Observation Therapy for the lower extremities will be applied to this group by their parents at home, 2 sessions a week for 6 weeks. Participants will be shown a video of a task by their parents at home. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip. Receives: Other: action observation therapy | |
| Group 3 | Children with spastic hemiparetic and diparetic CP included in our study were asked to watch and then perform the 6 activities in the video recording on a 10.2-inch tablet screen. The EGT program was applied for 20 minutes per day, 2 sessions per week for 6 weeks. Since there is no definitive protocol for children with diparetic CP, the EGT program applied is compatible with the protocol described by Sgandurra et al. In the application, the patient was asked to watch the activities in the video clip under the supervision of a physiotherapist, and after a one-minute rest period following each viewing, to repeat these activities physically actively for the duration of the video. After each EGT session, a 20-minute physiotherapy session was applied with a physiotherapist for the targets of the 6 activities. The scope of the applied physiotherapy consisted of activity-based exercises for the lower extremity, such as taking steps, weight transfer, balance and functionality. Receives: Other: action observation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function measured by Gross Motor Function Measure-88 (GMFM-88)
Gross motor function will be assessed using the GMFM-88, which consists of five dimensions. The D (Standing) and E (Walking, Running, Jumping) dimensions will be used in this study. Each item is scored on a 0-3 scale, and total scores are expressed as a percentage. A higher score indicates better gross motor function. The change in GMFM-88 scores from baseline to 150 days after the intervention will be evaluated.
Measured: Baseline and after 150 days
Secondary outcomes (6)
Change in muscle tone measured by Modified Ashworth Scale (MAS)
Muscle tone will be assessed using the MAS, a 6-point ordinal scale (0-4 with 1+ as an intermediate grade) that measures resistance during passive muscle stretching in individuals with upper motor neuron lesions. A higher score indicates greater spasticity.
Measured: Baseline and after 150 days
Change in balance function measured by Pediatric Balance Scale (PBS)
Balance function will be assessed using the PBS, which evaluates functional balance during activities requiring stability and transitions between postures. The total score ranges from 0 to 56, with higher scores indicating better balance performance.
Measured: Baseline and after 150 days
Change in dynamic balance measured by Pediatric Reach Test (PRT)
Dynamic balance will be evaluated using the PRT, which measures the maximal reach distance in centimeters (forward, right, and left directions) while standing. Greater reach distance indicates better dynamic balance.
Measured: Baseline and after 150 days
Change in functional mobility measured by Timed Up and Go Test (TUG)
Functional mobility will be assessed using the Timed Up and Go Test adapted for children with cerebral palsy. The time (in seconds) required to stand up from a chair, walk 3 meters, turn, return, and sit down will be recorded. A shorter time indicates better functional mobility.
Measured: Baseline and after 150 days
Change in activity level measured by Goal Attainment Scale (GAS)
Activity levels will be assessed using the GAS, which measures achievement of individualized therapy goals. Each goal is rated on a 5-point scale from -2 (much less than expected) to +2 (much more than expected). A higher score reflects better goal attainment.
Measured: Baseline and after 150 days
Change in participation measured by Child and Adolescent Scale of Participation (CASP)
Participation will be evaluated using the CASP, a caregiver-reported questionnaire assessing children's involvement in home, school, and community activities. The total score ranges from 0 to 100, with higher scores representing better participation.
Measured: Baseline and after 150 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start2 Dec 2022
- Primary completion15 Mar 2024
- Study completion7 Jul 2024
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.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Yıldız, Suleyman Demirel University
- Investigators
- hatice yakut, Study director, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247331
- Sponsor's protocol ID
- suleymanedu//Myildiz001
- Acronym
- AOT-CP
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2024
- Last updated
- 25 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.
PubMed 29764869Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
PubMed 17370477
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Action Observation Therapy on Spasticity, Gross Motor Function, Balance And Participation in Children With Cerebral Palsy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07247331
- Acronym / sponsor ID
- AOT-CP / suleymanedu//Myildiz001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 25 Nov 2025 (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.
In our randomized controlled study, which aims to investigate the contribution of Action Observation Therapy to rehabilitation by examining the effect of Action Observation Therapy on spasticity, gross motor function, balance and participation in children with spastic diplegic and hemiplegic cerebral palsy, the effectiveness of Action Observation Therapy to be applied in the home environment and accompanied by a physiotherapist will be investigated.
Detailed description
In this study, G*Power 3.1.3 program was used to calculate the minimum sample size in each group (control group (group 1), group 2 and group 3), in other words, the number of individuals in the groups. In this context, the effect size was taken as d = 1.1, the significance level was α = 0.05, and the minimum number of individuals in each group was calculated as 11 (33 in total) for a power of 0.80 (80%). Similar studies (Sgandurra 2013, Kim 2018) were taken into consideration in obtaining these parameters. The number of individuals in each group (+10%) was planned to be at least 12 (36 in total), taking into account individuals who were missing, incorrect or excluded from the study.
In order to prevent bias in terms of participants meeting the inclusion criteria, sociodemographic and clinical characteristics, criteria such as age, cerebral palsy type, GMFCS level and presence of comorbidities were taken into account in assigning individuals to groups in the study, and the stratified randomization method will be used. Accordingly, the age ranges are taken as 5-7, 8-10, 11-13, and the cerebral palsy type is; spastic diplegic and hemiplegic, GMFCS level; It will be taken as I-III and the stratification process will be done accordingly. Before the study, written and verbal "Informed Consent Form" will be obtained from the parents of all participants in the study and control groups. The content of the study will be explained to the children who will participate in the study in a way that the child can understand, and the child's consent will be obtained. After recording the sociodemographic data of the participants for both the experimental and control groups, their spasticity was measured by the Modified Ashworth Scale (MAS), their gross motor function levels were measured by the Gross Motor Function Measurement (GMFM), their participation was measured by the Child and Adolescent Participation Survey (CASP), and their balance was measured by the Timed Up and Go Test ( TUG), Pediatric Reach Test (PRT) and Pediatric Balance Scale (PDS), and the extent to which the individual goal has been achieved will be evaluated by the Goal Attainment Scale (GAS). Assessments will be administered the day before starting treatment, after completing the 6-week Action Observation Therapy, and after a 3-month follow-up period.
Treatment Program of the Control Group (Group 1): This group will not be shown any video clips, and general physiotherapy methods will be applied to their current needs, 2 sessions a week for 6 weeks. This method includes stretching exercises for spastic muscles, strengthening exercises for the antagonist of the spastic muscle, and stabilization exercises.
Group 2: Action Observation Therapy for the lower extremities will be applied to this group by their parents at home, 2 sessions a week for 6 weeks. Participants will be shown a video of a task by their parents at home. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip.
Group 3: Action Observation Therapy for the lower extremities will be applied by the therapist to this group, 2 sessions a week for 6 weeks. Participants will watch a video of a task presented by a therapist. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip. After each session of Action Observation Therapy, 20 minutes of physiotherapy will be applied towards the goals of 6 activities. The scope of physiotherapy to be applied will consist of activity-based exercises for the lower extremities, stepping, weight transfer, balance and functionality.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Program of the Control Group (Group 1): | – | Other: action observation therapyTreatment Program of the Control Group (Group 1): This group will not be shown any video clips, and general physiotherapy methods will be applied to their current needs, 2 sessions a week for 6 weeks. This method includes stretching exercises for spastic muscles, strengthening exercises for the antagonist of the spastic muscle, and stabilization exercises. |
| Group 2 | – | Other: action observation therapyAction Observation Therapy for the lower extremities will be applied to this group by their parents at home, 2 sessions a week for 6 weeks. Participants will be shown a video of a task by their parents at home. The video to be watched will include a total of 6 activities planned to be watched every week. These 6 activities; squatting and getting up by picking up an object from the ground, walking 10 steps between parallel lines, transferring weight forward with the right and left feet, walking 5 steps sideways to the right and left, kicking the ball, climbing the step from the front and side. The video clips will be watched 3 times and after a 1-minute rest following each viewing, the participants will be asked to repeat each activity in the videos 3 times and at the end of each clip. |
| Group 3 | – | Other: action observation therapyChildren with spastic hemiparetic and diparetic CP included in our study were asked to watch and then perform the 6 activities in the video recording on a 10.2-inch tablet screen. The EGT program was applied for 20 minutes per day, 2 sessions per week for 6 weeks. Since there is no definitive protocol for children with diparetic CP, the EGT program applied is compatible with the protocol described by Sgandurra et al. In the application, the patient was asked to watch the activities in the video clip under the supervision of a physiotherapist, and after a one-minute rest period following each viewing, to repeat these activities physically actively for the duration of the video. After each EGT session, a 20-minute physiotherapy session was applied with a physiotherapist for the targets of the 6 activities. The scope of the applied physiotherapy consisted of activity-based exercises for the lower extremity, such as taking steps, weight transfer, balance and functionality. |
Who may qualify
- Ages
- 5 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- In order to prevent bias in terms of participants meeting the inclusion criteria, sociodemographic and clinical characteristics, criteria such as age, CP type, GMFCS level and presence of comorbidities were taken into account in assigning individuals to groups in the study, and the stratified randomization method will be used. Accordingly, the age ranges are taken as 5-7, 8-10, 11-13, and the CP type is; spastic diplegic and hemiplegic, GMFCS level; It will be taken as I-III and the stratification process will be done accordingly.
Key inclusion criteria (4 listed)
- 5-13 years old
- Diagnosis of spastic hemiplegic and diplegic cerebral palsy
- Gross Motor Function Classification System (GMFCS) Level I-III
- Consent to participate in the study
Key exclusion criteria (5 listed)
- Spastic hemiplegic and diplegic disease not associated with cerebral palsy
- Presence of contractures affecting functional movement in the affected extremity
- Presence of cardiopulmonary disease or severe visual and hearing impairments
- Children who have had a seizure in the last 6 months
- Children who have had any surgery or received botulinum injections within the last 6 months or during the study period.
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 |
|---|---|---|
| action observation therapyAction Observation Therapy (AOT) is among the neurorehabilitation approaches that enable motor learning by facilitating neuroplasticity. AOT is based on neuroscience and activation of the mirror neuron system. AOT occurs in the form of the observer following the motor action and performing the observed actions after observing the actions. AOT aims to improve different motor functions by providing motor learning through neuroplasticity activation. | Other | Group 2, Group 3, Treatment Program of the Control Group (Group 1): |
Primary outcome
Change in Gross Motor Function measured by Gross Motor Function Measure-88 (GMFM-88)
Time frame: Baseline and after 150 days
Gross motor function will be assessed using the GMFM-88, which consists of five dimensions. The D (Standing) and E (Walking, Running, Jumping) dimensions will be used in this study. Each item is scored on a 0-3 scale, and total scores are expressed as a percentage. A higher score indicates better gross motor function. The change in GMFM-88 scores from baseline to 150 days after the intervention will be evaluated.
6 secondary outcomes
Change in muscle tone measured by Modified Ashworth Scale (MAS)
Time frame: Baseline and after 150 days
Change in balance function measured by Pediatric Balance Scale (PBS)
Time frame: Baseline and after 150 days
Change in dynamic balance measured by Pediatric Reach Test (PRT)
Time frame: Baseline and after 150 days
Change in functional mobility measured by Timed Up and Go Test (TUG)
Time frame: Baseline and after 150 days
Change in activity level measured by Goal Attainment Scale (GAS)
Time frame: Baseline and after 150 days
Change in participation measured by Child and Adolescent Scale of Participation (CASP)
Time frame: Baseline and after 150 days
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 25 Nov 2025.
- Results publication: PubMed 29764869Sgandurra G, Cecchi F, Beani E, Mannari I, Maselli M, Falotico FP, Inguaggiato E, Perazza S, Sicola E, Feys H, Klingels K, Ferrari A, Dario P, Boyd RN, Cioni G. Tele-UPCAT: study protocol of a randomised controlled trial of a home-based Tele-monitored UPper limb Children Action observation Training for participants with unilateral cerebral palsy. BMJ Open. 2018 May 14;8(5):e017819. doi: 10.1136/bmjopen-2017-017819.
- Results publication: PubMed 17370477Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
- Individual participant dataSharing planned: No
Related trials for Cerebral Palsy
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
RecruitingObservational study
Study of Sagittal Pelvic Statics in the Sitting Position in Children With Cerebral Palsy
Cerebral Palsy Infantile
Not yet recruitingObservational study
Turkish Translation, Cross-Cultural Adaptation, Validity, and Reliability of the ABILHAND-Kids Young CP Scale
Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)
Brainstem Stroke, ALS
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.
hatice yakut study director
Suleyman Demirel University
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 and Spastic Diplegia Cerebral Palsy, run by Suleyman Demirel 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 4 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: finished, as of the sponsor's last update on 25 Nov 2025. 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 Gross Motor Function measured by Gross Motor Function Measure-88 (GMFM-88) (time frame: Baseline and after 150 days). 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 NCT07247331, 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 25 Nov 2025.