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Completed

NCT Number: NCT03641651

New Technologies in the Rehabilitation of Chronic Stroke

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

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reha Rheinfelden, Rheinfelden, Switzerland

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rehabilitation technology

Other
  • 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 outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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)

  5. 10m Walk Test= TMT Comfortable

    Time frame: Baseline and 4 weeks

    time needed to walk 10 m with Comfortable walking speed

  6. 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

  7. 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

Sponsors and collaborators

Lead sponsor

Markus Wirz

Other

Collaborators

  • Klinik Lengg, Zurich
  • Klinik Valens
  • Reha Rheinfelden
  • Rehaklinik Zihlschlacht AG

Registry information

Official study 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

Acronym: SRTI

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 22, 2018
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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