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Mechanisms of Upper-Extremity Motor Recovery in Post-stroke Hemiparesis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00125658
First Posted: August 1, 2005
Last Update Posted: June 23, 2017
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.
Information provided by (Responsible Party):
VA Office of Research and Development
Results First Submitted: April 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cerebrovascular Accident
Interventions: Other: Control
Other: Experimental

  Participant Flow
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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
Order A (FTP Prior to Power) Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).
Order B (Power Prior to FTP) Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).

Participant Flow:   Overall Study
    Order A (FTP Prior to Power)   Order B (Power Prior to FTP)
STARTED   8   6 
COMPLETED   8   6 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Order A

Participants randomized to Order A received 10 weeks of functional task practice (FTP) followed by 10 weeks of upper-extremity power training (Power).

Single, unilateral stroke, >6 <26 months post-event.

Order B

Participants randomized to Order B received 10 weeks of upper-extremity Power Training followed by 10 weeks of functional task practice (FTP).

Single, unilateral stroke, >6 <26 months post-event.

Total Total of all reporting groups

Baseline Measures
   Order A   Order B   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   6   14 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      6  75.0%      4  66.7%      10  71.4% 
>=65 years      2  25.0%      2  33.3%      4  28.6% 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.5  (17.9)   64.2  (9.8)   59.8  (15) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  25.0%      0   0.0%      2  14.3% 
Male      6  75.0%      6 100.0%      12  85.7% 
Region of Enrollment 
[Units: Participants]
     
United States   8   6   14 


  Outcome Measures
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1.  Primary:   Change in Trunk Displacement   [ Time Frame: baseline, 10 weeks, 20 weeks ]

2.  Primary:   Change in Shoulder Flexion   [ Time Frame: baseline, 10 weeks, 20 weeks ]

3.  Primary:   Change in Elbow Extension Range of Motion   [ Time Frame: baseline, 10 weeks, 20 weeks ]

4.  Primary:   Upper-extremity Fugl-Meyer Motor Assessment   [ Time Frame: baseline, 10 weeks, 20 weeks ]

5.  Secondary:   Movement Speed   [ Time Frame: baseline, 10 weeks, 20 weeks ]

6.  Secondary:   Movement Accuracy (Reach Path Ratio, RPR)   [ Time Frame: baseline, 10 weeks, 20 weeks ]

7.  Secondary:   Movement Smoothness   [ Time Frame: baseline, 10 weeks, 20 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
This was a small clinical trial (total n = 14).


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Carolynn Patten
Organization: VA Brain Rehabilitation Research Center
phone: 352.376.1611 ext 4160
e-mail: carolynn.patten@va.gov


Publications of Results:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00125658     History of Changes
Other Study ID Numbers: B3964-R
First Submitted: July 28, 2005
First Posted: August 1, 2005
Results First Submitted: April 20, 2015
Results First Posted: June 23, 2017
Last Update Posted: June 23, 2017