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Functional Connectivity & Stimulation-enhanced Therapy Post Stroke

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ClinicalTrials.gov Identifier: NCT03473808
Recruitment Status : Completed
First Posted : March 22, 2018
Results First Posted : March 5, 2019
Last Update Posted : March 5, 2019
Sponsor:
Collaborators:
National Institute of General Medical Sciences (NIGMS)
University of Delaware
Information provided by (Responsible Party):
Na Jin Seo, Medical University of South Carolina

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stroke
Interventions Behavioral: task-practice therapy
Other: Vibration
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Therapy + Vibration
Hide Arm/Group Description

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Task-Practice Therapy: Standardized hand therapy program

Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level

Period Title: Overall Study
Started 5
Completed 4
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Therapy + Vibration
Hide Arm/Group Description

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Task-Practice Therapy: Standardized hand therapy program

Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
70  (5.18)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
0
   0.0%
Male
5
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
5
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Mean Change in Hand Motor Function
Hide Description Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Time Frame Baseline to approximately 1 week after the completion of 18 therapy sessions.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapy + Vibration
Hide Arm/Group Description:

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Task-Practice Therapy: Standardized hand therapy program

Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: blocks
0.83  (3.09)
2.Primary Outcome
Title Mean Change in Hand Motor Function
Hide Description Change in hand motor function as measured by the Box and Block Test. The test measures the number of blocks that a participant moves within one minute. The scale ranges from 0 to a positive number. Higher numbers represent better outcomes.
Time Frame Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapy + Vibration
Hide Arm/Group Description:

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Task-Practice Therapy: Standardized hand therapy program

Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: blocks
0.21  (1.18)
3.Secondary Outcome
Title Mean Change in Hand Motor Function
Hide Description Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.
Time Frame Baseline to approximately 1 week after the completion of 18 therapy sessions.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapy + Vibration
Hide Arm/Group Description:

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Task-Practice Therapy: Standardized hand therapy program

Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: seconds
-10.09  (3.66)
4.Secondary Outcome
Title Mean Change in Hand Motor Function
Hide Description Change in hand motor function as measured by the Wolf Motor Function Test Time. This test measures time to complete upper extremity movements in seconds. More negative values represent a greater reduction in time, thus better outcomes.
Time Frame Baseline to approximately 4 weeks after the completion of 18 therapy sessions.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Therapy + Vibration
Hide Arm/Group Description:

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Task-Practice Therapy: Standardized hand therapy program

Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level

Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: seconds
-14.24  (5.51)
Time Frame Baseline through one month follow-up (10 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Therapy + Vibration
Hide Arm/Group Description

Imperceptible vibration applied to the wrist during a standardized hand task practice therapy program.

Task-Practice Therapy: Standardized hand therapy program

Vibration: Peripheral vibration applied to the wrist skin at an imperceptible level

All-Cause Mortality
Therapy + Vibration
Affected / at Risk (%)
Total   0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Therapy + Vibration
Affected / at Risk (%) # Events
Total   0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Therapy + Vibration
Affected / at Risk (%) # Events
Total   4/5 (80.00%)    
General disorders   
Fall *  1/5 (20.00%)  2
Musculoskeletal and connective tissue disorders   
Temporary increase in muscle tone *  1/5 (20.00%)  3
Bumped affected upper extremity *  1/5 (20.00%)  2
Nervous system disorders   
Temporary upper extremity numbness *  2/5 (40.00%)  2
Worsening Monofilament Score   1/5 (20.00%)  2
Respiratory, thoracic and mediastinal disorders   
Cold *  2/5 (40.00%)  2
Skin and subcutaneous tissue disorders   
Temporary skin irritation *  2/5 (40.00%)  7
Surgical and medical procedures   
Root Canal *  1/5 (20.00%)  1
*
Indicates events were collected by non-systematic assessment
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Amanda Vatinno
Organization: Medical University of South Carolina
Phone: 8437924840
Responsible Party: Na Jin Seo, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03473808     History of Changes
Other Study ID Numbers: PRO74041
U54GM104941 ( U.S. NIH Grant/Contract )
First Submitted: March 5, 2018
First Posted: March 22, 2018
Results First Submitted: January 8, 2019
Results First Posted: March 5, 2019
Last Update Posted: March 5, 2019