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New Technologies in the Rehabilitation of Chronic Stroke (SRTI)

Primary Purpose

Stroke, Hemiplegia

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Rehabilitation technology
Sponsored by
Markus Wirz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Reha Rheinfelden
  • Kliniken Valens
  • Rehakliniken Zihlschlacht
  • Klinik Lengg AG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Technology arm

Arm Description

4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)
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.
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)
10m Walk Test= TMT Comfortable
time needed to walk 10 m with Comfortable walking speed
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
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

Full Information

First Posted
August 13, 2018
Last Updated
September 8, 2022
Sponsor
Markus Wirz
Collaborators
Klinik Lengg AG, Reha Rheinfelden, Klinik Valens, Rehaklinik Zihlschlacht AG
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1. Study Identification

Unique Protocol Identification Number
NCT03641651
Brief Title
New Technologies in the Rehabilitation of Chronic Stroke
Acronym
SRTI
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 31, 2018 (Actual)
Primary Completion Date
May 31, 2020 (Actual)
Study Completion Date
May 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Markus Wirz
Collaborators
Klinik Lengg AG, Reha Rheinfelden, Klinik Valens, Rehaklinik Zihlschlacht AG

4. Oversight

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
Data Monitoring Committee
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiplegia

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Technology arm
Arm Type
Experimental
Arm Description
4 Weeks intervention of intensive rehabilitation using rehabilitation technology, 3-5 h per day, within a 5d week in-or outpatient setting.
Intervention Type
Other
Intervention Name(s)
Rehabilitation technology
Other Intervention Name(s)
Lokomat, Erigo, Andago, Armeo (Boom, Senseo, Spring, Power), Valedo motion, Amadeo, Myro, NuStep, Bi-Manu Trainer, EksoGT, The Float, MOTOmed, Allegro
Intervention Description
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 Outcome Measure Information:
Title
Correlation Between Scheduled and Performed Trainings
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Functional Independence Measurement (FIM) Generic Functional Performance
Description
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)
Time Frame
Baseline and 4 weeks
Title
Stroke Impact Scale (SIS) Recovery
Description
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)
Time Frame
Baseline and 4 weeks
Title
Box and Block Test
Description
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.
Time Frame
Baseline and 4 weeks
Title
Functional Ambulation Categories (FAC)
Description
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)
Time Frame
Baseline and 4 weeks
Title
10m Walk Test= TMT Comfortable
Description
time needed to walk 10 m with Comfortable walking speed
Time Frame
Baseline and 4 weeks
Title
Walking Index of the Chedoke-McMaster Stroke Assessment Measure (CMSA)
Description
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
Time Frame
Baseline and 4 weeks
Title
Berg Balance Scale (BBS)
Description
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
Time Frame
Baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Reha Rheinfelden
City
Rheinfelden
ZIP/Postal Code
4310
Country
Switzerland
Facility Name
Kliniken Valens
City
Valens
ZIP/Postal Code
7317
Country
Switzerland
Facility Name
Rehakliniken Zihlschlacht
City
Zihlschlacht
ZIP/Postal Code
8588
Country
Switzerland
Facility Name
Klinik Lengg AG
City
Zürich
ZIP/Postal Code
8008
Country
Switzerland

12. IPD Sharing Statement

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New Technologies in the Rehabilitation of Chronic Stroke

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