ClinicalTrials.gg
RecruitingNCT06775925Armeo X-overUpdated Jul 8, 2026

Robot-assisted vs. Conventional Occupational Therapy of the Upper Limb in Individuals With Cervical Spinal Cord Injury

An interventional study of Unilateral robot-assisted therapy (RT) and Unilateral conventional occupational therapy (OT) in Cervical Spinal Cord Injury, sponsored by Swiss Paraplegic Research, Nottwil. Recruiting at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.

Sponsored by Swiss Paraplegic Research, Nottwil · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2025; still recruiting 1 year 9 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 47 studies in Spinal Cord Injuries by Swiss Paraplegic Research, Nottwil — 8 open to participants now, 8 under way, none of them phase 3. Spinal Cord Injuries · Swiss Paraplegic Research, Nottwil.

Planned enrollment
6th of 24
40 · median 20
Started
2025
with 3 others
No phase
20 of 47
6 open now
Registered
40th of 47
by date

Among the 47 studies in Spinal Cord Injuries by Swiss Paraplegic Research, Nottwil, this one is the 6th largest by planned enrollment of the 24 interventional ones that give a count, is one of 4 that started in 2025, is one of 20 with no phase, and was the 40th registered.

Spinal Cord Injuries

2,026 studies on the registry are indexed under Spinal Cord Injuries; 538 are open to participants now.

Browse Spinal Cord Injuries studies →

Open to participants now

8 of the 47 studies in Spinal Cord Injuries by Swiss Paraplegic Research, Nottwil are open now, in 3 countries. Recruiting first, the newest first:

2 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 47 studies in Spinal Cord Injuries by Swiss Paraplegic Research, Nottwil, or all of them as a file.
02

Study 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). 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)
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.

03

Conditions studied

  • Cervical Spinal Cord Injury

Keywords

  • upper limb function
  • robot-assisted therapy
  • occupational therapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • Participation in other interventional trials
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    RT-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.

    Other: Unilateral robot-assisted therapy (RT) · Other: Unilateral conventional occupational therapy (OT)

  • Experimental
    OT-RT

    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.

    Other: Unilateral robot-assisted therapy (RT) · Other: Unilateral conventional occupational therapy (OT)

Interventions

  • OtherUnilateral 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).

  • OtherUnilateral 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)

Secondary outcomes

  1. 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.

    Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)

  2. 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.

    Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)

  3. 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.

    Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)

  4. Handgrip strength

    dynamometer

    Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)

  5. Arm control

    Instrumented Action Research Arm Test (iARAT)

    Time frame: Baseline Assessment (week 1), Intermediate Assessment (week 7), Post Assessment (week 14), Follow-up Assessment (week 18)

  6. Therapy intensity

    amount of movement quantified by inertial measurement units (IMUs)

    Time frame: 18 times during the 12 weeks interventions

  7. 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).

    Time frame: 6 times during the 12 weeks interventions

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 30954153 ↗
  • Snoek 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 15224087 ↗
  • Singh 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 29334467 ↗
  • Lynskey 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 18566941 ↗
  • Kuchen 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 38063623 ↗
  • Kim 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 30206423 ↗
  • Jung 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 31499598 ↗
  • Anderson 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 ↗

Individual participant data

Plan to share: Yes — All IPD that underlie results in a publication.

Supporting information: Study protocol

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2025 (actual). Primary completion is estimated for Dec 2027, 34 months after the start.

Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 34 months is close to that.

Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2024
First posted
Jan 15, 2025
StartActual
Feb 1, 2025
Primary completionEst.
Dec 2027
CompletionEst.
Dec 2027
Last update
Jul 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06775925
Lead sponsor
Swiss Paraplegic Research, Nottwil
Responsible party
Sponsor
First posted
Jan 15, 2025
Start date
Feb 1, 2025
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Jul 8, 2026

Study contacts

Mario Widmer, Dr. sc. ETH
Contact
mario.widmer@paraplegie.ch
0041 41 939 51 97
Chantal Wunderlin
Contact
chantal.wunderlin@paraplegie.ch
0041 41 939 66 15

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion