Is there a dose-response relationship of robotic-assisted therapy in motor rehabilitation of the upper extremity after stroke? A Pilot Study with the Armeo®Spring.

Not Applicable

• Conditions: I60; I61; I62; I63; I64; Subarachnoid haemorrhage; Intracerebral haemorrhage; Other nontraumatic intracranial haemorrhage; Cerebral infarction; Stroke, not specified as haemorrhage or infarction

• Registration Number: DRKS00015083
• Lead Sponsor: urija Institut Kliniken Schmieder Allensbach

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-09-04
• Study Completion: 2019-04-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Ability to give informed consent for the participation in the study
2. Sufficient understanding of instructions
3. Ability to operate the Armeo®Spring
4. first cerebrovascular incident leading to hemiplegia, subacute phase < 3 months following incident
5. Movement of the arm possible if the weight of the arm is carried by a support (at least strength level 2 for shoulderjoint movement)
6. At least 18 years of age

Exclusion Criteria

1. prior history of neurological or psychiatric conditions
2. cognitive impairements that hinder the understanding of the study (e.g. receptive (Wernicke) aphasia, global aphasia, dementia)
3. participants demonstrating insufficient compliance
4. severe apraxia
5. severe neglect-relevant pain symptoms of the affected side of the body (>3 on the visual analoge scale [scale ranging from 0 to 10]
6. epilepsy or previous history of epileptic episodes
7. pregnancy
8. Presence of a [cardiac] pacemaker, implanted medical, electromedical or other devices
9. Presence of metallic and conductive inclusions or implants
10. Participants have tattoos in the head- or neckregions, nicotin patches or cosmetic manipulations of the eyelids (permanent make-up)
11. Participants suffering from claustrophobia
12. Participants with metalic contraceptives such as a contraceptive coil (possibly comprised of copper)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fugl-Meyer Assessment in upper limb (at baseline; Post-test after three weeks; Follow-up after another two weeks).

Secondary Outcome Measures

Name	Time	Method
Transcranial magnetic stimulation (single stimuli, cortical silent period (cSP) at stimulation intensity 120% above the individual threshold at baseline and after 3 weeks); Magnetic Resonance Imaging / Functional Magnetic Resonance Imaging (resting state fMRI, structural MRI, diffusion tensor imaging at baseline and after 3 weeks).