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

Condition(s) studied

Investigational drug(s) / intervention(s)

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).

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.

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)

Eligibility

Primary outcome measure(s)

• Grasp performance — 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).

Trial sites (1)

More Swiss Paraplegic Research, Nottwil trials in Switzerland

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