Tetraplegia/TetraparesisNCT06912217
Comparison of the Effects of Robotic Rehabilitation, Functional Electrical Stimulation and Occupational Therapy on Upper Extremity and Hand Functions in Tetraplegic Patients With Spinal Cord Injury
A study testing robotic rehabilitation, Functional Electrical Stimulation and occupational therapy in people with Tetraplegia/Tetraparesis, run by Ankara City Hospital Bilkent at 2 sites in Turkey (Türkiye).
Trial summary
2. Purpose and Significance of the Study (Primary and Secondary Objectives, if any) Spinal cord injury (SCI) is a clinical condition characterized by partial or total loss of motor, sensory, and autonomic functions below the level of the lesion, depending on the severity and level of the injury, which may be caused by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tetraplegia/Tetraparesis
- What is being tested?
- robotic rehabilitation, Functional Electrical Stimulation and occupational therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 30 Sep 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Incomplete tetraplegia
- No cognitive impairment (Mini-Mental State Exam score ≥25)
- No significant visual deficits
- Ability to sit upright for at least 30 minutes
- No prior exposure to these treatments in the last six months
Who cannot join
- Severe upper extremity spasticity (MAS score 3-4)
- Severe shoulder pain or joint ROM restriction (>50%)
- Pre-existing neurological, rheumatological, or orthopedic conditions affecting upper extremity
- Severe cardiovascular disease
- Uncontrolled aggressive behavior
- Open wounds or infections at application sites
Show all 9Show fewer
- Aphasia affecting comprehension
- Active deep vein thrombosis or thrombophlebitis in the upper extremity
- History of epilepsy or cyber disease
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Ankara Bilkent City Hospital
Ankara, Ankara
Ankara Bilkent City Hospital
Ankara, Çankaya
About this study
- Purpose and Significance of the Study (Primary and Secondary Objectives, if any) Spinal cord injury (SCI) is a clinical condition characterized by partial or total loss of motor, sensory, and autonomic functions below the level of the lesion, depending on the severity and level of the injury, which may be caused by traumatic or non-traumatic factors.
Globally, the incidence of SCI is estimated to be 250,000-500,000 cases per year . SCI patients may be classified as tetraplegic or paraplegic according to their functional levels. In paraplegia, there is a loss of function in both lower extremities, whereas tetraplegic patients experience functional loss in all four extremities. In both groups, autonomic dysfunctions in visceral organs can also be observed depending on the severity of the injury below the lesion level.
Read more
In tetraplegic patients, loss of upper extremity and hand functions significantly reduces their level of independence in daily living activities, particularly in self-care tasks, and considerably lowers their quality of life. Therefore, upper extremity and hand rehabilitation play a crucial role in the comprehensive rehabilitation program for tetraplegic patients. Various rehabilitative modalities have been used both in clinical practice and in the literature to improve upper extremity and hand functions. The use of advanced rehabilitation technologies has increased in recent years. Studies on functional electrical stimulation (FES) for upper extremity, robotic rehabilitation, virtual reality applications, mirror therapy, and similar approaches have become more prevalent in the literature . However, there is a limited number of studies comparing the superiority of these rehabilitation techniques in tetraplegic patients, leading to insufficient data for selecting the most appropriate rehabilitative technologies in clinical practice.
This study aims to compare the effects of FES, robotic rehabilitation, and occupational therapy on upper extremity and hand functions in tetraplegic patients. Additionally, it seeks to determine which patient groups, based on their clinical and demographic characteristics, would benefit the most from each therapy and to contribute to the development of personalized rehabilitation strategies by analyzing outcomes in the acute, subacute, and chronic phases of SCI.
- Conditions
- Tetraplegia/Tetraparesis
- Being tested
- robotic rehabilitation, Functional Electrical Stimulation, occupational therapy
- Keywords
- Spinal Cord Injury, Tetraplegia, Hand Functions, Occupational Therapy, Functional Electrical Stimulation, Robotic Rehabilitation
- Medical subject headings
- Quadriplegia, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic rehabilitationDevice
It is planned to provide a robotic rehabilitation program for patients in the robotic group, in addition to conventional rehabilitation for 4 weeks, with 30 minutes, 3 days a week, focusing only on their dominant upper extremities.
Functional Electrical StimulationDevice
In the FES group, an upper extremity FES bicycle program (ADI) will be applied to the dominant upper extremity and hand, three days a week for 4 weeks.
occupational therapyOther
In the occupational therapy group, patients will receive the planned treatment in addition to conventional rehabilitation for 4 weeks, three days a week, for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| robotic rehabilitation | Active comparator | It is planned to provide a robotic rehabilitation program for patients in the robotic group, in addition to conventional rehabilitation for 4 weeks, with 30 minutes, 3 days a week, focusing only on their dominant upper extremities. The program will be individualized for each patient through a treatment prescription consisting of games, tailored to their joint range of motion, muscle strength, functional status, skills, and perception. The goal is for patients to perform task-specific activities on a virtual screen using an exoskeleton (Armeo Power With Manova) robotic system. The robotic systems provide three-dimensional movement ability to the extremity with motor function loss. Receives: Device: Functional Electrical Stimulation; Other: occupational therapy |
| Occupational therapy | Active comparator | In the occupational therapy group, patients will receive the planned treatment in addition to conventional rehabilitation for 4 weeks, three days a week, for 30 minutes. Within the framework of this program, activities of daily living, especially self-care activities (eating, drinking, dressing, combing hair, brushing teeth, turning door handles, using remote controls, phones, and computers), as well as task-specific sensory and motor retraining and fine motor skills, will be worked on. Receives: Device: robotic rehabilitation; Device: Functional Electrical Stimulation |
| Functional Electrical Stimulation | Active comparator | In the FES group, an FES bicycle program (RT300 FES leg cycle) will be applied for 4 weeks, three days a week for 30 minutes, focusing on the dominant upper extremity and hand. Electrodes will be placed on the target muscle groups. Electrodes will be placed on the elbow flexors and extensors, wrist flexors and extensors, and finger flexors and extensors. The current intensity will be adjusted according to the patient's tolerance. Receives: Device: robotic rehabilitation; Other: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen-Taylor Hand Function Test
The test consists of seven subtests:
Writing a simple 24-letter sentence Turning over five cards Transferring small objects (e.g., buttons, jar lids, paper clips) from one container to another Simulating eating by lifting a dry bean from a plate to mouth level with a spoon Lifting empty large boxes from a table and placing them on a raised surface Lifting weighted boxes filled with objects from a table and placing them on a raised surface Stacking checkers on top of each other The patient's test completion time is recorded, and in each session, they aim to improve their previous performance.
Measured: Evaluation at Treatment Start and 4 Weeks Later
Nine-Hole Peg Test
This test will be used to evaluate fine motor skills.
The patient is seated at a table where the test materials are placed. The pegboard is positioned centrally on the table in front of the patient, and the pegs are placed on the side corresponding to the hand being tested.
The patient is instructed to insert the pegs into the holes as quickly as possible, in any order, using one peg at a time, until all nine holes are filled.
Immediately after filling all the holes, the patient is asked to remove the pegs one by one and return them to their original position without a break.
The timer starts when the patient touches the first peg and stops when the last peg is placed. Each hand will undergo two trials, and the average time will be recorded.
Measured: Evaluation at Treatment Start and 4 Weeks Later
Hand Grip Strength Assessment (Using a Dynamometer)
The hand grip strength of patients will be measured using a hand dynamometer.
Measurements will be taken with the patient seated, ensuring the following positioning:
Shoulder in adduction and close to the body
Elbow at 90 degrees of flexion
Wrist in 0-30 degrees of dorsiflexion and 0-15 degrees of ulnar deviation
Thumb facing upward
Each measurement will be repeated three times with 5-second intervals, and the average of the three measurements will be recorded in kilograms.
Measured: Evaluation at Treatment Start and 4 Weeks Later
Pinch Grip Strength (Pinchmeter)
Measurements will be taken in a seated position with the shoulder in adduction, the elbow in 90° flexion, and the forearm in a neutral position.
The measurements will be taken on the treated hand in three different positions: three-point, lateral, and tip-to-tip grips.
Three-point grip strength is evaluated by applying force to the pinchmeter placed between the distal phalanx of the thumb and the pulp of the second and third fingers.
Lateral grip strength is measured by placing the radial part of the middle phalanx of the index finger under the pinchmeter for support, while the distal phalanx of the thumb applies pressure on the pinchmeter from above.
Tip-to-tip grip strength is measured by placing the pinchmeter between the distal tip of the thumb and the distal tip of the index finger and compressing it.
Patients will be instructed to squeeze with maximum strength, and each measurement will be repeated three times. The averages will be recorded i
Measured: Evaluation at Treatment Start and 4 Weeks Later
American Spinal Injury Association (ASIA):
The ASIA (American Spinal Injury Association) Spinal Cord Injury Standard Neurological Classification is a standardized system used for classifying patients with spinal cord injuries. It is an examination scale that assesses motor function, sensory function, voluntary anal contraction, and deep anal sensation.
In the motor examination, 10 key muscle groups in both the upper and lower extremities are tested separately on the right and left sides. The sensory examination evaluates 28 dermatome areas for both light touch and pinprick sensation. A rectal examination is performed to assess voluntary anal sphincter control and the presence of deep anal sensation.
The neurological level of injury is determined, and a distinction between complete and incomplete injury is made.
Measured: Evaluation at Treatment Start and 4 Weeks Later
Secondary outcomes (4)
Modified Ashworth Scale (MAS)
MAS is a six-grade scale used to assess spasticity by evaluating the resistance perceived during the passive movement of a limb. In our study, it will be used to assess spasticity in the upper extremity and hand.
Measured: Evaluation at Treatment Start and 4 Weeks Later
ASIA Impairment Scale
Based on the results obtained from the ASIA classification system, the appropriate level for the patient is selected on the ASIA Impairment Scale, ranging from A to E.
Measured: Evaluation at Treatment Start and 4 Weeks Later
Joint Range of Motion Assessment
The assessment will be conducted using goniometric measurements for the upper extremity and hand, following international classification standards.
Measured: Evaluation at Treatment Start and 4 Weeks Later
Spinal Cord Injury Independence Measure (SCI Independence Measure) - Self-Care Subparameter
It is a scale used to assess functional activity limitations in spinal cord injury, evaluating a total of 17 activities, including personal care, respiration and sphincter management, and mobility. A Turkish validity and reliability study is available. In our study, the self-care subscale will be used.
The self-care subscale consists of four parameters: eating, bathing, dressing, and grooming. The total score ranges between 0 and 20 points.
Measured: Evaluation at Treatment Start and 4 Weeks Later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Apr 2025
- Primary completion1 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tetraplegia/TetraparesisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is designed as a parallel-group, open-label, prospective, randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Buse Arslan, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912217
- Sponsor's protocol ID
- Hilal Arslan 001
- Status last verified
- Dec 2025
- First submitted
- 29 Mar 2025
- Last updated
- 12 Jun 2026
- 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 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Robotic Rehabilitation, Functional Electrical Stimulation and Occupational Therapy on Upper Extremity and Hand Functions in Tetraplegic Patients With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06912217
- Acronym / sponsor ID
- Hilal Arslan 001
- Conditions
- Tetraplegia/Tetraparesis
- Keywords
- Spinal Cord Injury, Tetraplegia, Hand Functions, Occupational Therapy, Functional Electrical Stimulation, Robotic Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 4 Apr 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.
- Purpose and Significance of the Study (Primary and Secondary Objectives, if any) Spinal cord injury (SCI) is a clinical condition characterized by partial or total loss of motor, sensory, and autonomic functions below the level of the lesion, depending on the severity and level of the injury, which may be caused by traumatic or non-traumatic factors.
Globally, the incidence of SCI is estimated to be 250,000-500,000 cases per year . SCI patients may be classified as tetraplegic or paraplegic according to their functional levels. In paraplegia, there is a loss of function in both lower extremities, whereas tetraplegic patients experience functional loss in all four extremities. In both groups, autonomic dysfunctions in visceral organs can also be observed depending on the severity of the injury below the lesion level.
In tetraplegic patients, loss of upper extremity and hand functions significantly reduces their level of independence in daily living activities, particularly in self-care tasks, and considerably lowers their quality of life. Therefore, upper extremity and hand rehabilitation play a crucial role in the comprehensive rehabilitation program for tetraplegic patients. Various rehabilitative modalities have been used both in clinical practice and in the literature to improve upper extremity and hand functions. The use of advanced rehabilitation technologies has increased in recent years. Studies on functional electrical stimulation (FES) for upper extremity, robotic rehabilitation, virtual reality applications, mirror therapy, and similar approaches have become more prevalent in the literature . However, there is a limited number of studies comparing the superiority of these rehabilitation techniques in tetraplegic patients, leading to insufficient data for selecting the most appropriate rehabilitative technologies in clinical practice.
This study aims to compare the effects of FES, robotic rehabilitation, and occupational therapy on upper extremity and hand functions in tetraplegic patients. Additionally, it seeks to determine which patient groups, based on their clinical and demographic characteristics, would benefit the most from each therapy and to contribute to the development of personalized rehabilitation strategies by analyzing outcomes in the acute, subacute, and chronic phases of SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The study is designed as a parallel-group, open-label, prospective, randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| robotic rehabilitation | Active comparator | Device: Functional Electrical Stimulation, Other: occupational therapyIt is planned to provide a robotic rehabilitation program for patients in the robotic group, in addition to conventional rehabilitation for 4 weeks, with 30 minutes, 3 days a week, focusing only on their dominant upper extremities. The program will be individualized for each patient through a treatment prescription consisting of games, tailored to their joint range of motion, muscle strength, functional status, skills, and perception. The goal is for patients to perform task-specific activities on a virtual screen using an exoskeleton (Armeo Power With Manova) robotic system. The robotic systems provide three-dimensional movement ability to the extremity with motor function loss. |
| Occupational therapy | Active comparator | Device: robotic rehabilitation, Device: Functional Electrical StimulationIn the occupational therapy group, patients will receive the planned treatment in addition to conventional rehabilitation for 4 weeks, three days a week, for 30 minutes. Within the framework of this program, activities of daily living, especially self-care activities (eating, drinking, dressing, combing hair, brushing teeth, turning door handles, using remote controls, phones, and computers), as well as task-specific sensory and motor retraining and fine motor skills, will be worked on. |
| Functional Electrical Stimulation | Active comparator | Device: robotic rehabilitation, Other: occupational therapyIn the FES group, an FES bicycle program (RT300 FES leg cycle) will be applied for 4 weeks, three days a week for 30 minutes, focusing on the dominant upper extremity and hand. Electrodes will be placed on the target muscle groups. Electrodes will be placed on the elbow flexors and extensors, wrist flexors and extensors, and finger flexors and extensors. The current intensity will be adjusted according to the patient's tolerance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Incomplete tetraplegia
- No cognitive impairment (Mini-Mental State Exam score ≥25)
- No significant visual deficits
- Ability to sit upright for at least 30 minutes
Key exclusion criteria (9 listed)
- Severe upper extremity spasticity (MAS score 3-4)
- Severe shoulder pain or joint ROM restriction (>50%)
- Pre-existing neurological, rheumatological, or orthopedic conditions affecting upper extremity
- Severe cardiovascular disease
- Uncontrolled aggressive behavior
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 |
|---|---|---|
| robotic rehabilitationIt is planned to provide a robotic rehabilitation program for patients in the robotic group, in addition to conventional rehabilitation for 4 weeks, with 30 minutes, 3 days a week, focusing only on their dominant upper extremities. | Device | Functional Electrical Stimulation, Occupational therapy |
| Functional Electrical StimulationIn the FES group, an upper extremity FES bicycle program (ADI) will be applied to the dominant upper extremity and hand, three days a week for 4 weeks. | Device | Occupational therapy, robotic rehabilitation |
| occupational therapyIn the occupational therapy group, patients will receive the planned treatment in addition to conventional rehabilitation for 4 weeks, three days a week, for 30 minutes. | Other | Functional Electrical Stimulation, robotic rehabilitation |
Primary outcome
Jebsen-Taylor Hand Function Test
Time frame: Evaluation at Treatment Start and 4 Weeks Later
The test consists of seven subtests: Writing a simple 24-letter sentence Turning over five cards Transferring small objects (e.g., buttons, jar lids, paper clips) from one container to another Simulating eating by lifting a dry bean from a plate to mouth level with a spoon Lifting empty large boxes from a table and placing them on a raised surface Lifting weighted boxes filled with objects from a table and placing them on a raised surface Stacking checkers on top of each other The patient's test completion time is recorded, and in each session, they aim to improve their previous performance.
Nine-Hole Peg Test
Time frame: Evaluation at Treatment Start and 4 Weeks Later
This test will be used to evaluate fine motor skills. The patient is seated at a table where the test materials are placed. The pegboard is positioned centrally on the table in front of the patient, and the pegs are placed on the side corresponding to the hand being tested. The patient is instructed to insert the pegs into the holes as quickly as possible, in any order, using one peg at a time, until all nine holes are filled. Immediately after filling all the holes, the patient is asked to remove the pegs one by one and return them to their original position without a break. The timer starts when the patient touches the first peg and stops when the last peg is placed. Each hand will undergo two trials, and the average time will be recorded.
Hand Grip Strength Assessment (Using a Dynamometer)
Time frame: Evaluation at Treatment Start and 4 Weeks Later
The hand grip strength of patients will be measured using a hand dynamometer. Measurements will be taken with the patient seated, ensuring the following positioning: Shoulder in adduction and close to the body Elbow at 90 degrees of flexion Wrist in 0-30 degrees of dorsiflexion and 0-15 degrees of ulnar deviation Thumb facing upward Each measurement will be repeated three times with 5-second intervals, and the average of the three measurements will be recorded in kilograms.
Pinch Grip Strength (Pinchmeter)
Time frame: Evaluation at Treatment Start and 4 Weeks Later
Measurements will be taken in a seated position with the shoulder in adduction, the elbow in 90° flexion, and the forearm in a neutral position. The measurements will be taken on the treated hand in three different positions: three-point, lateral, and tip-to-tip grips. Three-point grip strength is evaluated by applying force to the pinchmeter placed between the distal phalanx of the thumb and the pulp of the second and third fingers. Lateral grip strength is measured by placing the radial part of the middle phalanx of the index finger under the pinchmeter for support, while the distal phalanx of the thumb applies pressure on the pinchmeter from above. Tip-to-tip grip strength is measured by placing the pinchmeter between the distal tip of the thumb and the distal tip of the index finger and compressing it. Patients will be instructed to squeeze with maximum strength, and each measurement will be repeated three times. The averages will be recorded i
American Spinal Injury Association (ASIA):
Time frame: Evaluation at Treatment Start and 4 Weeks Later
The ASIA (American Spinal Injury Association) Spinal Cord Injury Standard Neurological Classification is a standardized system used for classifying patients with spinal cord injuries. It is an examination scale that assesses motor function, sensory function, voluntary anal contraction, and deep anal sensation. In the motor examination, 10 key muscle groups in both the upper and lower extremities are tested separately on the right and left sides. The sensory examination evaluates 28 dermatome areas for both light touch and pinprick sensation. A rectal examination is performed to assess voluntary anal sphincter control and the presence of deep anal sensation. The neurological level of injury is determined, and a distinction between complete and incomplete injury is made.
4 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Evaluation at Treatment Start and 4 Weeks Later
ASIA Impairment Scale
Time frame: Evaluation at Treatment Start and 4 Weeks Later
Joint Range of Motion Assessment
Time frame: Evaluation at Treatment Start and 4 Weeks Later
Spinal Cord Injury Independence Measure (SCI Independence Measure) - Self-Care Subparameter
Time frame: Evaluation at Treatment Start and 4 Weeks Later
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 12 Jun 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic rehabilitation, Functional Electrical Stimulation and occupational therapy in people with Tetraplegia/Tetraparesis, run by Ankara City Hospital Bilkent at 2 sites 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 9 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Jebsen-Taylor Hand Function Test (time frame: Evaluation at Treatment Start and 4 Weeks Later). The study lists 5 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 12 Jun 2026.