Cervical Spinal Cord InjuryArmeo X-overNCT06775925
Robot-assisted vs. Conventional Occupational Therapy of the Upper Limb in Individuals With Cervical Spinal Cord Injury
A study testing Unilateral robot-assisted therapy (RT) and Unilateral conventional occupational therapy (OT) in people with Cervical Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
Trial summary
The goal of this clinical trial is to learn the effects of robot-assisted therapy using the ArmeoSpring on upper limb function compared to conventional occupational therpay in individuals with cervical spinal cord injury (cSCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cervical Spinal Cord Injury
- What is being tested?
- Unilateral robot-assisted therapy (RT) and Unilateral conventional occupational therapy (OT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Informed Consent signed by the subject
- Intermediate (>16 days and ≤81 days post-injury) traumatic or non-traumatic cSCI during primary rehabilitation at the Swiss Paraplegic Centre (SPC)
- Neurological level of injury: C1-T1
- American Spinal Injury Association Impairment Scale (AIS): A-D
- Impairment of upper limb function (GRASSP-QtG score unilateral < 25 at baseline t0)
- Ability to sit for 60 minutes and perform training with ArmeoSpring
- Stratification parameters available
Who cannot join
- Inability to follow the procedures of the investigation
- Severe concomitant neurological disease
- Concomitant neurodegenerative or progressive diseases
- Impairment of upper limb function due to peripheral nerve lesions
- Severe concurrent medical disease or any other issue that in the opinion of the investigator would confound the results
- Orthopedic limitations of the upper limb
- Device specific contraindications
- Participation in other interventional trials
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Swiss Paraplegic Centre
Nottwil, Canton of Lucerne, 6207
Mario Widmer, Dr. sc. ETH, 0041419395197, mario.widmer@paraplegie.ch
About this study
Official title: Robot-assisted vs. Conventional Occupational Therapy of the Upper Limb in Individuals With Cervical Spinal Cord Injury: The Armeo X-over Trial
The goal of this clinical trial is to learn the effects of robot-assisted therapy using the ArmeoSpring on upper limb function compared to conventional occupational therpay in individuals with cervical spinal cord injury (cSCI). The main questions it aims to answer are:
- Which of the two forms of therapy, robot-assisted therapy or conventional occupational therapy, is more effective in terms of improving arm and hand function?
Read more
The study is designed as a cross-over trial, which means that each participant will receive both therapy forms consecutively, whereas the order is assigned randomly (either robot-assisted therapy first and then occupational therapy, or vice versa).
In addition to their clinical routine therapy , participants will:
- complete a baseline assessment
- practice one therapy form (either robot-assisted or occupational therapy) with one arm for 6 weeks (3 x 30 min per week)
- complete a intermediate assessment
- practice the other therapy form (either occupational or robot-assisted therapy) with one arm for 6 weeks (3 x 30 min per week)
- complete a post assessment
- complete a follow-up assessment (if the post assessment was completed prior to 150 days post-injury)
Read the detailed description
After cervical spinal cord injury (cSCI), motor and sensory impairments cause limitations in upper limb function which affect performance of activities of daily living (ADLs), independence and, ultimately, restrict participation and quality of life. Previous studies have shown that individuals with tetraplegia consider improvements in upper limb function to be one of the most significant factors in improving their quality of life. Small improvements in upper extremity function through rehabilitation can lead to substantial increases in independence with ADLs, quality of life and community integration. Repetitive and activity-based exercise can facilitate recovery after SCI by inducing practice-dependent brain and spinal plasticity. To achieve high numbers of repetitions, specialised rehabilitation centres apply innovative therapy methods like robot-assisted therapy (RT) aiming to improve upper limb function. Integrating robotic devices into daily clinical practice may save personnel resources while enabling high-intensive and individualised therapy using motivating feedback (e.g., gamification) and allowing for close monitoring of therapy sessions. Evidence suggests that robot-assisted interventions are safe, feasible and can reduce active assistance provided by therapists.
However, the clinical effectiveness of robot-assisted interventions for patients after cSCI has not been proven so far. For the devices used at the Swiss Paraplegic Centre (SPC) for upper extremity therapy after cSCI, there are only two studies to date that have followed a randomised controlled trial (RCT) design, and both were conducted with inadequate methodological quality (e.g. recruitment period one or two years post-injury respectively). This introduces a lot of variance and it thus remains open whether RT and conventional occupational therapy (OT) just have similar effects, or whether potential effects have been blurred due to imprecise study designs. Moreover, while both RCTs used the actively supporting ArmeoPower, internal analyses have shown that the passively supporting ArmeoSpring is the by far mostly used robotic device for training of the upper extremity inhouse. The ArmeoSpring is an instrumented arm orthosis with a spring mechanism (no actuators) for adjustable antigravity weight support for the arm in a large 3D workspace. However, neither of these robotic devices has ever been properly evaluated for clinical effectiveness .
Therefore, the aim of this study is to systematically investigate the effects of robot-assisted therapy (using the ArmeoSpring) on upper limb function compared to conventional occupational therapy in individuals with intermediate (between 2 weeks and 6 months after injury) cSCI.
- Conditions
- Cervical Spinal Cord Injury
- Being tested
- Unilateral robot-assisted therapy (RT), Unilateral conventional occupational therapy (OT)
- Keywords
- upper limb function, robot-assisted therapy, occupational therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral robot-assisted therapy (RT)Other
RT will be performed as an add-on therapy to the clinical routine therapy scheme for 3 x 30 minutes per week for 6 weeks. RT is applied using the ArmeoSpring, an exoskeleton that provides adjustable antigravity weight support for the arm through a system of springs (no actuators).
Unilateral conventional occupational therapy (OT)Other
The OT is applied as add-on therapy for 3 x 30 minutes per week for 6 weeks. OT comprises strengthening exercises (concentric and eccentric) with and without resistance, grasping exercises, fine motor training, peg games, and activity-based tasks which are unilaterally doable.
| Study group | Role | What they receive |
|---|---|---|
| RT-OT | Experimental | A stratified randomisation procedure will be used to allocate the sequence with either RT followed by OT or vice versa. The participants will performe unilateral robot-asssited therapy for 3 x 30 minutes per week for 6 weeks first, and then the unilateral conventional occupational therapy also for 3 x 30 minutes per week for 6 weeks. Receives: Other: Unilateral robot-assisted therapy (RT); Other: Unilateral conventional occupational therapy (OT) |
| OT-RT | Experimental | A stratified randomisation procedure will be used to allocate the sequence with either OT followed by RT or vice versa. The participants will perform unilateral conventional occupational therapy for 3 x 30 minutes per week for 6 weeks first, and then unilateral robot-assisted therapy also for 3 x 30 minutes per week for 6 weeks. Receives: Other: Unilateral robot-assisted therapy (RT); Other: Unilateral conventional occupational therapy (OT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grasp performance
Quantitative subtest of Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP-QtG).
6 GRASSP-QtG tasks in total, each task is graded from 0 (the task cannot be conducted at all) to 5 (the task is conducted without difficulties using the expected grasping pattern and upper limb function is unaffected).
Measured: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Secondary outcomes (7)
Qualitative upper limb function
Qualitative, sensation and strength subtest of GRASSP. 3 prehension ability tasks, of which each task is graded from 0 (the task cannot be conducted at all) to 4 (the task is conducted without difficulties and appropriate force) for each arm.
Measured: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Independence in ADL
Spinal Cord Independence Measure III - Self-report (SCIM-SR). The SCIM-SR is assessed in 3 domains. The first domain "Self-Care" consists of 6 items and the scores range from 0 (e.g. full support needed) to 20 (e.g. completely independent). The second domain "Respiration and sphincter management" include 4 items whereas the third domain " Mobility" contain 9 items, both with scores from 0 - 40. Thus, the total score of SCIM-SR ranges from 0 to 100.
Measured: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Upper Extremity Motor Score
International Standards for the Neurological Classification of Spinal Cord Injury examination (ISNCSCI-UEMS).
Manual muscle testing of 5 upper extremity movements is conducted and scored. Each score is graded between 0 (no palpable or visible muscle contraction) to 5 (Full range of motion against maximum resistance) by the medical research council scale.
Measured: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Handgrip strength
dynamometer
Measured: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Arm control
Instrumented Action Research Arm Test (iARAT)
Measured: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Therapy intensity
amount of movement quantified by inertial measurement units (IMUs)
Measured: 18 times during the 12 weeks interventions
Intrinsic Motivation
Intrinsic Motivation Inventory (IMI). The full IMI includes 45 items distributed across seven subscales, of which the applicable items and subscales can be chosen. Each item is graded between 1 (not at all true) to 7 (very true).
Measured: 6 times during the 12 weeks interventions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start1 Feb 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Cervical Spinal Cord InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, assessor-blind, two-period, crossover trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Swiss Paraplegic Research, Nottwil
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06775925
- Sponsor's protocol ID
- 2020-22
- Acronym
- Armeo X-over
- Status last verified
- Jul 2026
- First submitted
- 24 Dec 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Publications
Yozbatiran N, Francisco GE. Robot-assisted Therapy for the Upper Limb after Cervical Spinal Cord Injury. Phys Med Rehabil Clin N Am. 2019 May;30(2):367-384. doi: 10.1016/j.pmr.2018.12.008. Epub 2019 Mar 2.
PubMed 30954153Snoek GJ, IJzerman MJ, Hermens HJ, Maxwell D, Biering-Sorensen F. Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics. Spinal Cord. 2004 Sep;42(9):526-32. doi: 10.1038/sj.sc.3101638.
PubMed 15224087Singh H, Unger J, Zariffa J, Pakosh M, Jaglal S, Craven BC, Musselman KE. Robot-assisted upper extremity rehabilitation for cervical spinal cord injuries: a systematic scoping review. Disabil Rehabil Assist Technol. 2018 Oct;13(7):704-715. doi: 10.1080/17483107.2018.1425747. Epub 2018 Jan 15.
PubMed 29334467Lynskey JV, Belanger A, Jung R. Activity-dependent plasticity in spinal cord injury. J Rehabil Res Dev. 2008;45(2):229-40. doi: 10.1682/jrrd.2007.03.0047.
PubMed 18566941Kuchen DB, Hubacher B, Ladner A, Velstra IM, Widmer M. Technology-Assisted Upper Limb Therapy (TAULT): Evaluation of Clinical Practice at a Specialised Centre for Spinal Cord Injury in Switzerland. Healthcare (Basel). 2023 Nov 28;11(23):3055. doi: 10.3390/healthcare11233055.
PubMed 38063623Kim J, Lee BS, Lee HJ, Kim HR, Cho DY, Lim JE, Kim JJ, Kim HY, Han ZA. Clinical efficacy of upper limb robotic therapy in people with tetraplegia: a pilot randomized controlled trial. Spinal Cord. 2019 Jan;57(1):49-57. doi: 10.1038/s41393-018-0190-z. Epub 2018 Sep 11.
PubMed 30206423Jung JH, Lee HJ, Cho DY, Lim JE, Lee BS, Kwon SH, Kim HY, Lee SJ. Effects of Combined Upper Limb Robotic Therapy in Patients With Tetraplegic Spinal Cord Injury. Ann Rehabil Med. 2019 Aug;43(4):445-457. doi: 10.5535/arm.2019.43.4.445. Epub 2019 Aug 31.
PubMed 31499598Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
PubMed 15672628
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robot-assisted vs. Conventional Occupational Therapy of the Upper Limb in Individuals With Cervical Spinal Cord Injury: The Armeo X-over Trial
- ClinicalTrials.gov ID
- NCT06775925
- Acronym / sponsor ID
- Armeo X-over / 2020-22
- Conditions
- Cervical Spinal Cord Injury
- Keywords
- upper limb function, robot-assisted therapy, occupational therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Swiss Paraplegic Research, NottwilResearch network
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 Jan 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.
The goal of this clinical trial is to learn the effects of robot-assisted therapy using the ArmeoSpring on upper limb function compared to conventional occupational therpay in individuals with cervical spinal cord injury (cSCI). The main questions it aims to answer are:
- Which of the two forms of therapy, robot-assisted therapy or conventional occupational therapy, is more effective in terms of improving arm and hand function?
The study is designed as a cross-over trial, which means that each participant will receive both therapy forms consecutively, whereas the order is assigned randomly (either robot-assisted therapy first and then occupational therapy, or vice versa).
In addition to their clinical routine therapy , participants will:
- complete a baseline assessment
- practice one therapy form (either robot-assisted or occupational therapy) with one arm for 6 weeks (3 x 30 min per week)
- complete a intermediate assessment
- practice the other therapy form (either occupational or robot-assisted therapy) with one arm for 6 weeks (3 x 30 min per week)
- complete a post assessment
- complete a follow-up assessment (if the post assessment was completed prior to 150 days post-injury)
Detailed description
After cervical spinal cord injury (cSCI), motor and sensory impairments cause limitations in upper limb function which affect performance of activities of daily living (ADLs), independence and, ultimately, restrict participation and quality of life. Previous studies have shown that individuals with tetraplegia consider improvements in upper limb function to be one of the most significant factors in improving their quality of life. Small improvements in upper extremity function through rehabilitation can lead to substantial increases in independence with ADLs, quality of life and community integration. Repetitive and activity-based exercise can facilitate recovery after SCI by inducing practice-dependent brain and spinal plasticity. To achieve high numbers of repetitions, specialised rehabilitation centres apply innovative therapy methods like robot-assisted therapy (RT) aiming to improve upper limb function. Integrating robotic devices into daily clinical practice may save personnel resources while enabling high-intensive and individualised therapy using motivating feedback (e.g., gamification) and allowing for close monitoring of therapy sessions. Evidence suggests that robot-assisted interventions are safe, feasible and can reduce active assistance provided by therapists.
However, the clinical effectiveness of robot-assisted interventions for patients after cSCI has not been proven so far. For the devices used at the Swiss Paraplegic Centre (SPC) for upper extremity therapy after cSCI, there are only two studies to date that have followed a randomised controlled trial (RCT) design, and both were conducted with inadequate methodological quality (e.g. recruitment period one or two years post-injury respectively). This introduces a lot of variance and it thus remains open whether RT and conventional occupational therapy (OT) just have similar effects, or whether potential effects have been blurred due to imprecise study designs. Moreover, while both RCTs used the actively supporting ArmeoPower, internal analyses have shown that the passively supporting ArmeoSpring is the by far mostly used robotic device for training of the upper extremity inhouse. The ArmeoSpring is an instrumented arm orthosis with a spring mechanism (no actuators) for adjustable antigravity weight support for the arm in a large 3D workspace. However, neither of these robotic devices has ever been properly evaluated for clinical effectiveness .
Therefore, the aim of this study is to systematically investigate the effects of robot-assisted therapy (using the ArmeoSpring) on upper limb function compared to conventional occupational therapy in individuals with intermediate (between 2 weeks and 6 months after injury) cSCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, assessor-blind, two-period, crossover trial
| Arm | Type | Receives |
|---|---|---|
| RT-OT | Experimental | Other: Unilateral robot-assisted therapy (RT), Other: Unilateral conventional occupational therapy (OT)A stratified randomisation procedure will be used to allocate the sequence with either RT followed by OT or vice versa. The participants will performe unilateral robot-asssited therapy for 3 x 30 minutes per week for 6 weeks first, and then the unilateral conventional occupational therapy also for 3 x 30 minutes per week for 6 weeks. |
| OT-RT | Experimental | Other: Unilateral robot-assisted therapy (RT), Other: Unilateral conventional occupational therapy (OT)A stratified randomisation procedure will be used to allocate the sequence with either OT followed by RT or vice versa. The participants will perform unilateral conventional occupational therapy for 3 x 30 minutes per week for 6 weeks first, and then unilateral robot-assisted therapy also for 3 x 30 minutes per week for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed Consent signed by the subject
- Intermediate (>16 days and ≤81 days post-injury) traumatic or non-traumatic cSCI during primary rehabilitation at the Swiss Paraplegic Centre (SPC)
- Neurological level of injury: C1-T1
- American Spinal Injury Association Impairment Scale (AIS): A-D
- Impairment of upper limb function (GRASSP-QtG score unilateral < 25 at baseline t0)
Key exclusion criteria (8 listed)
- Inability to follow the procedures of the investigation
- Severe concomitant neurological disease
- Concomitant neurodegenerative or progressive diseases
- Impairment of upper limb function due to peripheral nerve lesions
- Severe concurrent medical disease or any other issue that in the opinion of the investigator would confound the results
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 |
|---|---|---|
| Unilateral robot-assisted therapy (RT)RT will be performed as an add-on therapy to the clinical routine therapy scheme for 3 x 30 minutes per week for 6 weeks. RT is applied using the ArmeoSpring, an exoskeleton that provides adjustable antigravity weight support for the arm through a system of springs (no actuators). | Other | OT-RT, RT-OT |
| Unilateral conventional occupational therapy (OT)The OT is applied as add-on therapy for 3 x 30 minutes per week for 6 weeks. OT comprises strengthening exercises (concentric and eccentric) with and without resistance, grasping exercises, fine motor training, peg games, and activity-based tasks which are unilaterally doable. | Other | OT-RT, RT-OT |
Primary outcome
Grasp performance
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Quantitative subtest of Graded Redefined Assessment of Strength, Sensibility, and Prehension (GRASSP-QtG). 6 GRASSP-QtG tasks in total, each task is graded from 0 (the task cannot be conducted at all) to 5 (the task is conducted without difficulties using the expected grasping pattern and upper limb function is unaffected).
7 secondary outcomes
Qualitative upper limb function
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Independence in ADL
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Upper Extremity Motor Score
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Handgrip strength
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Arm control
Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)
Therapy intensity
Time frame: 18 times during the 12 weeks interventions
Intrinsic Motivation
Time frame: 6 times during the 12 weeks interventions
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Background: PubMed 30954153Yozbatiran N, Francisco GE. Robot-assisted Therapy for the Upper Limb after Cervical Spinal Cord Injury. Phys Med Rehabil Clin N Am. 2019 May;30(2):367-384. doi: 10.1016/j.pmr.2018.12.008. Epub 2019 Mar 2.
- Background: PubMed 15224087Snoek GJ, IJzerman MJ, Hermens HJ, Maxwell D, Biering-Sorensen F. Survey of the needs of patients with spinal cord injury: impact and priority for improvement in hand function in tetraplegics. Spinal Cord. 2004 Sep;42(9):526-32. doi: 10.1038/sj.sc.3101638.
- Background: PubMed 29334467Singh H, Unger J, Zariffa J, Pakosh M, Jaglal S, Craven BC, Musselman KE. Robot-assisted upper extremity rehabilitation for cervical spinal cord injuries: a systematic scoping review. Disabil Rehabil Assist Technol. 2018 Oct;13(7):704-715. doi: 10.1080/17483107.2018.1425747. Epub 2018 Jan 15.
- Background: PubMed 18566941Lynskey JV, Belanger A, Jung R. Activity-dependent plasticity in spinal cord injury. J Rehabil Res Dev. 2008;45(2):229-40. doi: 10.1682/jrrd.2007.03.0047.
- Background: PubMed 38063623Kuchen DB, Hubacher B, Ladner A, Velstra IM, Widmer M. Technology-Assisted Upper Limb Therapy (TAULT): Evaluation of Clinical Practice at a Specialised Centre for Spinal Cord Injury in Switzerland. Healthcare (Basel). 2023 Nov 28;11(23):3055. doi: 10.3390/healthcare11233055.
- Background: PubMed 30206423Kim J, Lee BS, Lee HJ, Kim HR, Cho DY, Lim JE, Kim JJ, Kim HY, Han ZA. Clinical efficacy of upper limb robotic therapy in people with tetraplegia: a pilot randomized controlled trial. Spinal Cord. 2019 Jan;57(1):49-57. doi: 10.1038/s41393-018-0190-z. Epub 2018 Sep 11.
- Background: PubMed 31499598Jung JH, Lee HJ, Cho DY, Lim JE, Lee BS, Kwon SH, Kim HY, Lee SJ. Effects of Combined Upper Limb Robotic Therapy in Patients With Tetraplegic Spinal Cord Injury. Ann Rehabil Med. 2019 Aug;43(4):445-457. doi: 10.5535/arm.2019.43.4.445. Epub 2019 Aug 31.
- Background: PubMed 15672628Anderson KD. Targeting recovery: priorities of the spinal cord-injured population. J Neurotrauma. 2004 Oct;21(10):1371-83. doi: 10.1089/neu.2004.21.1371.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral robot-assisted therapy (RT) and Unilateral conventional occupational therapy (OT) in people with Cervical Spinal Cord Injury, run by Swiss Paraplegic Research, Nottwil at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mario Widmer, Dr. sc. ETH (0041 41 939 51 97, mario.widmer@paraplegie.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grasp performance (time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)). 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 NCT06775925, which also lists 8 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 8 Jul 2026.