New Technologies in the Rehabilitation of Chronic Stroke (SRTI)

September 8, 2022 updated by: Markus Wirz

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Rheinfelden, Switzerland, 4310
        • Reha Rheinfelden
      • Valens, Switzerland, 7317
        • Kliniken Valens
      • Zihlschlacht, Switzerland, 8588
        • Rehakliniken Zihlschlacht
      • Zürich, Switzerland, 8008
        • Klinik Lengg AG

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Technology arm
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
  • 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
Other Names:
  • Lokomat
  • MOTOmed
  • Erigo
  • Andago
  • Armeo (Boom, Senseo, Spring, Power)
  • Valedo motion
  • Amadeo
  • Myro
  • NuStep
  • Bi-Manu Trainer
  • EksoGT
  • The Float
  • Allegro

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation Between Scheduled and Performed Trainings
Time Frame: 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.
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Markus Wirz

Collaborators

Klinik Valens
Rehaklinik Zihlschlacht AG
Reha Rheinfelden
Klinik Lengg AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2018

Primary Completion (ACTUAL)

May 31, 2020

Study Completion (ACTUAL)

May 31, 2020

Study Registration Dates

First Submitted

August 13, 2018

First Submitted That Met QC Criteria

August 17, 2018

First Posted (ACTUAL)

August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZHAW-SRTI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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