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SRTI: New Technologies in the Rehabilitation of Chronic Stroke

Sponsor
Markus Wirz (Other)
Overall Status
Completed
CT.gov ID
NCT03641651
Collaborator
Klinik Lengg AG (Other), Reha Rheinfelden (Other), Klinik Valens (Other), Rehaklinik Zihlschlacht AG (Other)
14
Enrollment
4
Locations
1
Arm
21
Actual Duration (Months)
3.5
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation technology
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
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
Actual Study Start Date :
Aug 31, 2018
Actual Primary Completion Date :
May 31, 2020
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

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
  • Erigo
  • Andago
  • Armeo (Boom, Senseo, Spring, Power)
  • Valedo motion
  • Amadeo
  • Myro
  • NuStep
  • Bi-Manu Trainer
  • EksoGT
  • The Float
  • MOTOmed
  • Allegro

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Adherence to training [4 weeks]

      ratio between planned training duration and actually performed training duration in minutes

    Secondary Outcome Measures

    1. Functional independence measurement (FIM) [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

    2. Stroke impact scale (SIS) [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)

    3. Box and Block test [4 weeks]

      measures broader motoric function of the arm and hand as a performance test. subjects are required to grab and sort 150 wooden blocks from one side of small dividing wall set up on a table in front of the sitting subject to another side. Time measured to perform this activity in seconds and minutes

    4. Functional ambulation categories (FAC) [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)

    5. Comfortable walking speed (10m Walk test= TMT) [4 weeks]

      time needed to walk 10 m

    6. Walking index of the Chedoke-McMaster Stroke Assessment Measure (CMSA) [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)

    7. Berg Balance scale (BBS) [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Reha Rheinfelden Rheinfelden Switzerland 4310
    2 Kliniken Valens Valens Switzerland 7317
    3 Rehakliniken Zihlschlacht Zihlschlacht Switzerland 8588
    4 Klinik Lengg AG Zürich Switzerland 8008

    Sponsors and Collaborators

    • Markus Wirz
    • Klinik Lengg AG
    • Reha Rheinfelden
    • Klinik Valens
    • Rehaklinik Zihlschlacht AG

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Markus Wirz, Head of Physiotherapy R&D, Zurich University of Applied Sciences
    ClinicalTrials.gov Identifier:
    NCT03641651
    Other Study ID Numbers:
    • ZHAW-SRTI
    First Posted:
    Aug 22, 2018
    Last Update Posted:
    Jul 1, 2020
    Last Verified:
    Jun 1, 2020
    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
    Additional relevant MeSH terms:
    Stroke
    Hemiplegia
    Frovatriptan

    Study Results

    No Results Posted as of Jul 1, 2020