New Technologies in the Rehabilitation of Chronic Stroke

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

• Rehabilitation technology (Other), also known as Lokomat, Erigo, Andago, Armeo (Boom, Senseo, Spring, Power), Valedo motion, Amadeo, Myro, NuStep, Bi-Manu Trainer, EksoGT, The Float, MOTOmed, Allegro: * 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

Primary outcomes

• Correlation Between Scheduled and Performed Trainings [4 weeks]: 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.

Secondary outcomes

• Functional Independence Measurement (FIM) Generic Functional Performance [Baseline and 4 weeks]: 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)
• Stroke Impact Scale (SIS) Recovery [Baseline and 4 weeks]: 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)
• Box and Block Test [Baseline and 4 weeks]: 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.
• Functional Ambulation Categories (FAC) [Baseline and 4 weeks]: 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)
• 10m Walk Test= TMT Comfortable [Baseline and 4 weeks]: time needed to walk 10 m with Comfortable walking speed
• Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA) [Baseline and 4 weeks]: 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
• Berg Balance Scale (BBS) [Baseline and 4 weeks]: 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

Sex: All, ages: 18 Years to 99 Years

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.

Participant flow

Outcome results

• Correlation Between Scheduled and Performed Trainings (Primary), Number, correlation coefficient: Technology Arm 0.56 (0.50 to 0.61)
• Functional Independence Measurement (FIM) Generic Functional Performance (Secondary), Mean, units on a scale: Technology Arm 102 +/- 47.5
• Stroke Impact Scale (SIS) Recovery (Secondary), Mean, units on a scale: Technology Arm 50 +/- 35
• Box and Block Test (Secondary), Mean, blocks/60 sec: Technology Arm 0 +/- 19.8
• Functional Ambulation Categories (FAC) (Secondary), Median, units on a scale: Technology Arm 2 (0 to 5)
• 10m Walk Test= TMT Comfortable (Secondary), Mean, seconds: Technology Arm 28.6 +/- 22.9
• Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA) (Secondary), Mean, units on a scale: Technology Arm 16 +/- 8.3
• Berg Balance Scale (BBS) (Secondary), Mean, units on a scale: Technology Arm 32 +/- 24

Adverse events

Time frame: over the 4 weeks rehabilitation period

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• Study Protocol and Statistical Analysis Plan (PDF, 2018-09-12)