RecruitingNot ApplicableNCT06775925

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

Robot-assisted Vs. Conventional Occupational Therapy of the Upper Limb in Individuals with Cervical Spinal Cord Injury: the Armeo X-over Trial


Sponsor

Swiss Paraplegic Research, Nottwil

Enrollment

40 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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

Exclusion Criteria8

  • 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

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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.


Locations(1)

Swiss Paraplegic Centre

Nottwil, Canton of Lucerne, Switzerland

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NCT06775925


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