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SunRISe Study - Stroke Rehabilitation In Suriname (SunRISe)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717715
Recruitment Status : Completed
First Posted : March 24, 2016
Last Update Posted : July 19, 2017
Sponsor:
Collaborators:
Anton De Kom University
VU University of Amsterdam
Information provided by (Responsible Party):
Roselien Buys, KU Leuven

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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Home base stroke rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. Change in peak oxygen uptake [ Time Frame: 4 weeks, 8 weeks and 5 months after start of rehabilitation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT02717715


Locations
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Suriname
Anton De Kom University
Paramaribo, Suriname
Sponsors and Collaborators
KU Leuven
Anton De Kom University
VU University of Amsterdam
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Responsible Party: Roselien Buys, Dr., KU Leuven
ClinicalTrials.gov Identifier: NCT02717715    
Other Study ID Numbers: VG 023-15
First Posted: March 24, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases