New Technologies in the Rehabilitation of Chronic Stroke

Study Overview
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Brief Summary
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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

Detailed Description
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This feasibility project aims to establish an efficient setting for intensive rehabilitation with new technology in four trailblazer clinics. This will enable them to provide intensive therapy to the patients in accordance with the study protocol. If this setting is integrated into the clinical routine, the investigators will be able to collect data to get some first insight into economic and functional data required to calculate changes in socioeconomic costs

Official Title
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Feasibility and Cost Description of Intensive Rehabilitation Involving New Technologies in Patients With Sub-acute Stroke:A Multicenter Single Arm Trial of the Swiss RehabTech Initiative

Conditions
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Stroke, Hemiplegia

Intervention / Treatment
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* Other: Rehabilitation technology


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Technology arm<br>4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting. | Other: Rehabilitation technology<br>* Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training. With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1). A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days. Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen. The training can take place in an outpatient or inpatient setting. Training will be organized in individual one-to-one or group session<br>* Other names: Allegro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between Scheduled and Performed Trainings | Adherence was operationalized by correlating planned trainings with trainings which were carried out by the participants. Due to the small sample size Spearman's rank correlation was used. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Independence Measurement (FIM) Generic Functional Performance | observer based measurement of the subject performing basic functional tests, e.g. sitting-up from lying position, stand-up from sitting, walking, stair-climbing etc. Observer rate on a scale from 1 to 7 (1= totally dependent on aid, 7= totally independent) for each activity 18 items, that would led to a score from 18 (totally dependent) to 126 (totally independent) | Baseline and 4 weeks | 
| Stroke Impact Scale (SIS) Recovery | Questionnaire to be completed by the patient, regarding different parts in daily life: 1. physical problems: 4 items, 2. memory and thinking: 7 items, 3. mood and emotional control: 9 items, 4. communication and understanding: 7 items, 5.daily activities: 10 items, 6. mobility at home and community: 9 items, 7. hand function: 5 items, 8. participation in life: 8 items. each item should be rated on on 5-point Lickert scale with 1= extremely difficult OR can't do at all OR no strength at all OR all the time AND 5 means: a lot of strength OR not difficult at all OR none of the time OR Question 9 regarding recovery from stroke rated on a scale from 0 - 100 (0= no recovery, 100= full recovery) | Baseline and 4 weeks | 
| Box and Block Test | Measures broader motoric function of the arm and hand as a performance test. Subjects are required to grab and sort wooden blocks from one side of a small dividing wall set up on a table in front of the sitting subject to another side. The unit of the measure is the amount of blocks transferred within 60 seconds. | Baseline and 4 weeks | 
| Functional Ambulation Categories (FAC) | Observer based measurement to rate the ability to walk independently. Rated from 0 to 6 (0= not able to walk independently, 6= can walk independently in every situation) | Baseline and 4 weeks | 
| 10m Walk Test= TMT Comfortable | time needed to walk 10 m with Comfortable walking speed | Baseline and 4 weeks | 
| Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA) | The Walking Index consists of the 5 following items: Walking indoors Walking outdoors, over rough ground, ramps, and curbs Walking outdoors several blocks Stairs Age and sex appropriate walking distance in meters for 2 minutes scored on a 7-point scale (Stage 1 through 7, most impairment through to no impairment, respectively) score from 5 to 35 points, the more points the better | Baseline and 4 weeks | 
| Berg Balance Scale (BBS) | Observer based measurement of walking, standing and balance with 14 items/task to perform by the subject and rated each on scale from 0 to 4 (0= not able to do without help, 4 = can do safely and independently) score between 0 to 56, the more the better | Baseline and 4 weeks |