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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSwiss Paraplegic Research, Nottwil

About this 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?

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Unilateral robot-assisted therapy (RT)

    Other intervention

    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 intervention

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: RT-OTExperimental treatment 2 interventions
Group B: OT-RTExperimental treatment 2 interventions

Trial outcomes

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)

Other outcomes

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