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SunRISe Study - Stroke Rehabilitation In Suriname (SunRISe)

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

Suriname

Study Type

Interventional

Intervention

Home base stroke rehabilitation

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

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

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)

Sites / Locations

Anton De Kom University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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.

The participants in the control group will only receive usual care.

Outcomes

Primary Outcome Measures

Change in peak oxygen uptake

Secondary Outcome Measures

Full Information

NCT ID

NCT02717715

First Posted

March 5, 2016

Last Updated

July 18, 2017

Sponsor

KU Leuven

Collaborators

Anton De Kom University, VU University of Amsterdam

1. Study Identification

Unique Protocol Identification Number

NCT02717715

Brief Title

SunRISe Study - Stroke Rehabilitation In Suriname

Acronym

SunRISe

Official Title

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.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Anton De Kom University, VU University of Amsterdam

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

The participants in the control group will only receive usual care.

Intervention Type

Behavioral

Intervention Name(s)

Home base stroke rehabilitation

Intervention Description

The intervention consists of physiotherapy exercises targeting functional and physical capacity.

Primary Outcome Measure Information:

Title

Change in peak oxygen uptake

Time Frame

4 weeks, 8 weeks and 5 months after start of rehabilitation

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

Facility Name

Anton De Kom University

City

Paramaribo

Country

Suriname

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

SunRISe Study - Stroke Rehabilitation In Suriname

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