Trial Outcomes & Findings for Functional Connectivity & Stimulation-enhanced Therapy Post Stroke (NCT NCT03473808)

Last Updated: 2019-03-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

Baseline to approximately 1 week after the completion of 18 therapy sessions.

Results posted on

2019-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Therapy + Vibration 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 Study STARTED	5
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Therapy + Vibration 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 Study Withdrawal by Subject	1

Baseline Characteristics

Functional Connectivity & Stimulation-enhanced Therapy Post Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Therapy + Vibration n=5 Participants 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
Age, Continuous	70 years STANDARD_DEVIATION 5.18 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to approximately 1 week after the completion of 18 therapy sessions.

Outcome measures

Outcome measures
Measure	Therapy + Vibration n=4 Participants 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
Mean Change in Hand Motor Function	0.83 blocks Standard Deviation 3.09

PRIMARY outcome

Timeframe: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.

Outcome measures

Outcome measures
Measure	Therapy + Vibration n=4 Participants 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
Mean Change in Hand Motor Function	0.21 blocks Standard Deviation 1.18

SECONDARY outcome

Timeframe: Baseline to approximately 1 week after the completion of 18 therapy sessions.

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.

Outcome measures

Outcome measures
Measure	Therapy + Vibration n=4 Participants 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
Mean Change in Hand Motor Function	-10.09 seconds Standard Deviation 3.66

SECONDARY outcome

Timeframe: Baseline to approximately 4 weeks after the completion of 18 therapy sessions.

Outcome measures

Outcome measures
Measure	Therapy + Vibration n=4 Participants 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
Mean Change in Hand Motor Function	-14.24 seconds Standard Deviation 5.51

Adverse Events

Therapy + Vibration

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Therapy + Vibration n=5 participants at risk 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
Surgical and medical procedures Root Canal	20.0% 1/5 • Number of events 1 • Baseline through one month follow-up (10 weeks).
Respiratory, thoracic and mediastinal disorders Cold	40.0% 2/5 • Number of events 2 • Baseline through one month follow-up (10 weeks).
General disorders Fall	20.0% 1/5 • Number of events 2 • Baseline through one month follow-up (10 weeks).
Musculoskeletal and connective tissue disorders Temporary increase in muscle tone	20.0% 1/5 • Number of events 3 • Baseline through one month follow-up (10 weeks).
Musculoskeletal and connective tissue disorders Bumped affected upper extremity	20.0% 1/5 • Number of events 2 • Baseline through one month follow-up (10 weeks).
Nervous system disorders Temporary upper extremity numbness	40.0% 2/5 • Number of events 2 • Baseline through one month follow-up (10 weeks).
Skin and subcutaneous tissue disorders Temporary skin irritation	40.0% 2/5 • Number of events 7 • Baseline through one month follow-up (10 weeks).
Nervous system disorders Worsening Monofilament Score	20.0% 1/5 • Number of events 2 • Baseline through one month follow-up (10 weeks).

Additional Information

Amanda Vatinno

Medical University of South Carolina

Phone: 8437924840

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place