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N/A N=15 Health Services Research

New Technologies in the Rehabilitation of Chronic Stroke

Stroke · Hemiplegia

Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Correlation Between Scheduled and Performed Trainings — 0.56 correlation coefficient

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Rehabilitation technology (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Markus Wirz
Primary completion
May 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Correlation Between Scheduled and Performed Trainings
0.56
SECONDARY
Functional Independence Measurement (FIM) Generic Functional Performance
102; 104.5
SECONDARY
Stroke Impact Scale (SIS) Recovery
50; 65.5
SECONDARY
Box and Block Test
0; 1
SECONDARY
Functional Ambulation Categories (FAC)
2; 3.5
SECONDARY
10m Walk Test= TMT Comfortable
28.6; 19.0
SECONDARY
Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)
16; 19
SECONDARY
Berg Balance Scale (BBS)
32; 39

Summary

The objective of the current study is to develop and investigate training concepts involving rehabilitation technology, which aim at exploiting the potential for regaining the ability to perform skilled movements by maximizing training intensity and keeping the motivation of patients high. The evaluation focuses on feasibility and cost-benefit analyses

Eligibility Criteria

Inclusion Criteria

  • Adult patients with residual hemiparesis after cerebrovascular accident
  • Up to 12 months after the event
  • Primary rehabilitation terminated
  • Able to cognitively comprehend the aim of the project with at least 22 points in the Montreal Cognitive Assessment (MoCA)
  • General health condition allows for intensive rehabilitative training with limited supervision i.e. clearance and prescription of responsible physician
  • Understand written and spoken German language

Exclusion Criteria

Patients with any signs and symptoms showing that the participant is unwilling to participate in the study will result in the patient being excluded from participation Any medical condition preventing participation such as Severe respiratory disease Severe OR unstable cardio-circulatory conditions Orthopaedic conditions, especially in extremities targeted for rehabilitation such as

  • fixed joint contractures limiting range of motion
  • non-consolidated fractures Neuro-psychological conditions including cognitive deficits limiting communication or non-cooperation like (self-) aggressive behaviour Infections or inflammatory diseases, like osteomyelitis

Specific absolute contraindication for the training with any of the respective devices:

  • Improper fit of the device, including its harness to relevant extremity(ies)
  • Contraindicated training position (standing, sitting)

Device specific contraindications will be respected and will lead to the exclusion of the device for that patient.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03641651). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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