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New Technologies in the Rehabilitation of Chronic Stroke (SRTI)

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ClinicalTrials.gov Identifier: NCT03641651
Recruitment Status : Recruiting
First Posted : August 22, 2018
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
Klinik Lengg AG
Reha Rheinfelden
Klinik Valens
Rehaklinik Zihlschlacht AG
Information provided by (Responsible Party):
Markus Wirz, Zurich University of Applied Sciences

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
Stroke Hemiplegia Other: Rehabilitation technology Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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 : August 31, 2018
Estimated Primary Completion Date : July 15, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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




Primary Outcome Measures :
  1. Adherence to training [ Time Frame: 4 weeks ]
    ratio between planned training duration and actually performed training duration in minutes


Secondary Outcome Measures :
  1. Functional independence measurement (FIM) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 4 weeks ]
    time needed to walk 10 m

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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641651


Contacts
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Contact: Markus Wirz, PhD +41 58 934 6321 markus.wirz@zhaw.ch
Contact: Markus J Ernst, MSc +41 58 934 6448 markus.ernst@zhaw.ch

Locations
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Switzerland
Reha Rheinfelden Recruiting
Rheinfelden, Switzerland, 4310
Contact: Corina Schuster-Amft, PhD         
Kliniken Valens Recruiting
Valens, Switzerland, 7317
Contact: Jan Kool, PhD         
Rehakliniken Zihlschlacht Not yet recruiting
Zihlschlacht, Switzerland, 8588
Contact: Carsten Möller, MD         
Klinik Lengg AG Recruiting
Zürich, Switzerland, 8008
Contact: Christian Sturzenegger, MD         
Contact: Ludwig Schmid, PT         
Sponsors and Collaborators
Markus Wirz
Klinik Lengg AG
Reha Rheinfelden
Klinik Valens
Rehaklinik Zihlschlacht AG

Publications:

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Responsible Party: Markus Wirz, Head of Physiotherapy R&D, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier: NCT03641651     History of Changes
Other Study ID Numbers: ZHAW-SRTI
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms