Trial Outcomes & Findings for Treatment of Hand Dysfunction After Stroke (NCT NCT00508521)

Results Overview

A subscale of the Fugl-Meyer; the Fugl-Meyer Upper Limb Coordination Scale is a measure of movement coordination in and out of synergy patterns for the hemiparetic upper limb; scores range from 0-66, with 0 being the worst score and 66 being the best score.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

baseline and after 12 weeks of training

Results posted on

2014-02-07

Participant Flow

Subjects were recruited through the use of study flier and by word of mouth.

All subjects enrolled in the study were entered into the same arm of this pilot study

Participant milestones

Participant milestones
Measure	FES and Motor Learning Training Group Subjects \< 6 months following first stroke who had diminished upper limb strength, coordination and function.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Hand Dysfunction After Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 Subjects With Acute Stroke n=4 Participants Subjects \< 6 months following first stroke who had diminished upper limb strength, coordination and function.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and after 12 weeks of training

A subscale of the Fugl-Meyer; the Fugl-Meyer Upper Limb Coordination Scale is a measure of movement coordination in and out of synergy patterns for the hemiparetic upper limb; scores range from 0-66, with 0 being the worst score and 66 being the best score.

Outcome measures

Outcome measures
Measure	Arm 1 Subjects With Acute Stroke n=4 Participants Subjects \< 6 months following first stroke who had diminished upper limb strength, coordination and function.
Fugl-Meyer Upper Limb Coordination Scale (FMUE) Pre-Treatment Fugl Meyer Upper Limb Score	27.75 units on a scale Standard Deviation 3.86
Fugl-Meyer Upper Limb Coordination Scale (FMUE) Post-Treatment Fugl Meyer Upper Limb Score	48.50 units on a scale Standard Deviation 3.16

Adverse Events

Arm 1 Subjects With Acute Stroke

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Janis Daly, Ph.D., M.S.; Director, Brain Rehabilitation Research Center

Malcom Randall VA Medical Center, Gainesville Florida

Phone: (352) 376-1611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place