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Technology-assisted Rehabilitation After Acute Stroke

Primary Purpose

Stroke

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Technology-assisted rehabilitation
Conventional rehabilitation
Sponsored by
Vetrea Terveys Oy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

Inclusion Criteria:

  • age 18 or more
  • first stroke

Exclusion Criteria:

  • unstable cardiopulmonary condition
  • severe cognitive disorder
  • aphasia

Sites / Locations

  • VetreaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Technology-assisted rehabilitation

Conventional rehabilitation

Arm Description

Augmented exercise therapy with novel technology

Traditional multidisciplinary rehabilitation

Outcomes

Primary Outcome Measures

WHODAS 2.0
World Health Organization Disability Assessment Schedule - 12 questions scoring 1 to 5 yielding a total score from 12 to 60. A higher score means an increasing disability.
service use and costs
amount and costs of social and health care services used

Secondary Outcome Measures

PROMIS Global 10
Patient Reported Outcome Measurement Information System - a generic global health scale v1.2 consists of 10 questions across 6 health items. Two of the items (Physical and Mental) can be converted to T-scores allowing comparisons to a general population.
FAC
Functional Ambulation Categories - categorical scale ranging from 0 (unable to walk) to 5 (independent walking without assistive devices on any surfaces).
Hand grip force
hand grip
Shoulder elevation test
shoulder range of motion

Full Information

First Posted
November 30, 2020
Last Updated
April 14, 2021
Sponsor
Vetrea Terveys Oy
Collaborators
Kuopio University Hospital, City of Kuopio
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1. Study Identification

Unique Protocol Identification Number
NCT04647812
Brief Title
Technology-assisted Rehabilitation After Acute Stroke
Official Title
Technology-assisted Rehabilitation After Acute Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vetrea Terveys Oy
Collaborators
Kuopio University Hospital, City of Kuopio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to evaluate the effects and costs of an intensified rehabilitation for stroke patients. Using novel technologies the patients will receive an augmented exercise therapy during the first weeks after stroke. The effects on restoration of functions as well as on the costs incurred from social and health care services will be assessed and compared to the conventional rehabilitation over 6 month follow-up.
Detailed Description
The intervention consists of technology-assisted multidisciplinary rehabilitation for 3 weeks followed by an 8-week period of supervised home-based telerehabilitation and a weekly group exercise in an outpatient clinic. The effects on mobility, upper extremity motor functions and activities of daily living will be assessed using FAC, hand grip force, shoulder elevation test, WHODAS 2.0 and PROMIS scales. The costs incurred from social and health care services over 6 months will be compared to the control group receiving conventional rehabilitation. Patients aged 18 or more with their first stroke and stable cardiopulmonary condition will be consecutively recruited first into the control group (n=20) and thereafter into the experimental group (n=20). Patients with a severe cognitive deficit or aphasia will be excluded.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Consecutive cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Technology-assisted rehabilitation
Arm Type
Experimental
Arm Description
Augmented exercise therapy with novel technology
Arm Title
Conventional rehabilitation
Arm Type
Experimental
Arm Description
Traditional multidisciplinary rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Technology-assisted rehabilitation
Intervention Description
Augmented exercise therapy with novel technology and home-based telerehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Conventional rehabilitation
Intervention Description
Traditional multidisciplinary in-patient rehabilitation
Primary Outcome Measure Information:
Title
WHODAS 2.0
Description
World Health Organization Disability Assessment Schedule - 12 questions scoring 1 to 5 yielding a total score from 12 to 60. A higher score means an increasing disability.
Time Frame
6 months
Title
service use and costs
Description
amount and costs of social and health care services used
Time Frame
6 months
Secondary Outcome Measure Information:
Title
PROMIS Global 10
Description
Patient Reported Outcome Measurement Information System - a generic global health scale v1.2 consists of 10 questions across 6 health items. Two of the items (Physical and Mental) can be converted to T-scores allowing comparisons to a general population.
Time Frame
6 months
Title
FAC
Description
Functional Ambulation Categories - categorical scale ranging from 0 (unable to walk) to 5 (independent walking without assistive devices on any surfaces).
Time Frame
6 months
Title
Hand grip force
Description
hand grip
Time Frame
6 months
Title
Shoulder elevation test
Description
shoulder range of motion
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 18 or more first stroke Exclusion Criteria: unstable cardiopulmonary condition severe cognitive disorder aphasia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kauko Pitkänen, MD, PhD
Phone
0505965289
Ext
358
Email
kauko.pitkanen@vetrea.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Airaksinen
Phone
0407291908
Ext
358
Email
laura.airaksinen@vetrea.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kauko Pitkänen, MD, PhD
Organizational Affiliation
Vetrea Terveys Oy
Official's Role
Study Director
Facility Information:
Facility Name
Vetrea
City
Kuopio
State/Province
North Savo
ZIP/Postal Code
71130
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kauko Pitkänen, PhD
Phone
+358505965289
Email
kauko.pitkanen@vetrea.fi

12. IPD Sharing Statement

Learn more about this trial

Technology-assisted Rehabilitation After Acute Stroke

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