ClinicalTrials.gov
ClinicalTrials.gov Menu

Client Centred 'Tune-ups': do They Enhance Community Reintegration After Stroke?

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: NCT00400712
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : May 5, 2016
Last Update Posted : May 5, 2016
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
Dr. Brenda Brouwer, Queen's University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stroke
Intervention: Behavioral: physical rehabilitation

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control no intervention, natural history following stroke
Intervention two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year)

Participant Flow:   Overall Study
    Control   Intervention
STARTED   52   51 
COMPLETED   35   35 
NOT COMPLETED   17   16 
Death                1                0 
Withdrawal by Subject                11                12 
Physician Decision                5                4 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Hemiparetic stroke (hemorrhagic or ischemic), first ever associated with residual deficits/impairments (i.e. full recovery from previous stoke if applicable)

Reporting Groups
  Description
Control natural progression post-stroke
Intervention

two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)

physical rehabilitation: two weeks intensive physical rehabilitation

Total Total of all reporting groups

Baseline Measures
   Control   Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 52   51   103 
Age 
[Units: Years]
Mean (Standard Deviation)
 62.1  (1.8)   62.7  (1.7)   62.3  (1.8) 
Gender 
[Units: Participants]
     
Female   22   27   49 
Male   30   24   54 
Admission Functional Independence [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 96.2  (23.4)   100.5  (22.1)   98.4  (22.7) 
[1] The Functional Independence Measure (FIM) is an instrument that provides an indication of an individual's level of disability and their ability to perform activities of daily living (ADL). Eighteen (18) ADL-related motor and cognitive items are each rated on an ordinal scale ranging from complete dependence (1) to complete independence (7). The total FIM score ranges from 18 (lowest) to 126 (highest, complete independence).
Balance ability [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 45.4  (13.5)   47.8  (11.9)   46.6  (12.8) 
[1] The Berg Balance Scale (BBS) is composed of 14 items that require the individual to perform specific balance tasks ranging from basic (e.g. sit-to-stand, unsupported standing) to more difficult (e.g. standing on one leg). Each item is scored on an ordinal scale from 0 (unable to perform) to 4 (able to complete independently and/or safely). The total score ranges from 0 (lowest) to 56 (highest).
living setting pre-stroke 
[Units: Participants]
     
private home   51   50   101 
other   1   1   2 
mental status (MMSE) [1] 
[Units: Points]
Mean (Standard Deviation)
 28  (0)   28  (0)   28  (0) 
[1] The Mini-Mental State Exam (MMSE) is a screening tool for cognitive impairment. It is an 11 item questionnaire that tests five areas of cognitive function including orientation, attention and recall. A maximum score is 30 (total number of correct responses, 1 to 5 per question). A score of 23 or lower indicates cognitive impairment.
paretic side 
[Units: Participants]
     
left hemiparesis   37   29   66 
right hemiparesis   15   22   37 


  Outcome Measures

1.  Primary:   Subjective Index of Physical and Social Outcome (SIPSO)   [ Time Frame: baseline and 1 year ]

2.  Primary:   Subjective Index of Social Integration (Subscale of SIPSO)   [ Time Frame: baseline and one year ]

3.  Primary:   Subjective Index of Physical Integration (Subscale of SIPSO)   [ Time Frame: baseline and one year ]

4.  Secondary:   Mobility Function   [ Time Frame: baseline and 1 year ]

5.  Secondary:   Physical Capacity   [ Time Frame: baseline and 12 months ]

6.  Secondary:   Health-related Quality of Life - Physical   [ Time Frame: baseline and one year ]

7.  Secondary:   Health-related Quality of Life - Mental   [ Time Frame: baseline and one year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Brenda Brouwer
Organization: Queen's University
phone: 613-533-6079
e-mail: brouwerb@queensu.ca



Responsible Party: Dr. Brenda Brouwer, Queen's University
ClinicalTrials.gov Identifier: NCT00400712     History of Changes
Other Study ID Numbers: HS SRA 5974
First Submitted: November 16, 2006
First Posted: November 17, 2006
Results First Submitted: November 6, 2015
Results First Posted: May 5, 2016
Last Update Posted: May 5, 2016