SunRISe Study - Stroke Rehabilitation In Suriname (SunRISe)

July 18, 2017 updated by: Roselien Buys, KU Leuven

The Effect of a Tele-supervised Home Based Rehabilitation Program on Physical Fitness, Quality of Gait, Upper Limb Disability and Quality of Life in People After Chronic Stroke in a Urban Setting in Suriname. Randomised Controlled Trial.

This study aims to determine the effect of a supervised home-based physical fitness program on the aerobic capacity, quality of gait and health related quality of life in people with chronic ischemic stroke. Secondly, feasibility of the program for implementing a long term lifestyle change will be investigated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Suriname
      • Paramaribo, Suriname
        • Anton De Kom University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ability to give informed consent
  • ability to understand measurement procedures defined as MMSE >24
  • last stroke >6 months ago
  • mild to moderate stroke deficit defined by Fugl Meyer test score of 27 to 90 for upper and lower extremities
  • FAC ≥3
  • medical clearance to participate in a moderate exercise program
  • living at home and having a minimum of 5 stairs at home

Exclusion Criteria:

  • serious cardiac condition
  • other serious end organ damage
  • other neurological deficits leading to disability
  • uncontrolled blood pressure (systolic pressure >140, diastolic pressure >90)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Stroke patients from the intervention group will be, on top of usual care, offered a holistic home based and semi-supervised stroke rehabilitation program followed by a period of tele-supervision.
Behavioral: Home base stroke rehabilitation
The intervention consists of physiotherapy exercises targeting functional and physical capacity.
No Intervention: Control group
The participants in the control group will only receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in peak oxygen uptake
Time Frame: 4 weeks, 8 weeks and 5 months after start of rehabilitation
4 weeks, 8 weeks and 5 months after start of rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

VU University of Amsterdam
Anton De Kom University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 5, 2016

First Submitted That Met QC Criteria

March 18, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Actual)

July 19, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VG 023-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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