Trial Outcomes & Findings for Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity (NCT NCT00462449)

Results Overview

upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

23 participants

Primary outcome timeframe

12 weeks

Results posted on

2014-06-20

Participant Flow

Recruitment period from 11/15/2007 through 10/05/2009. Subjects were recruited primarily from the PI's clinical patient pool with unilateral, upper extremity spasticity. All subjects were required to be at least 6 months post insult.

Participant milestones

Participant milestones
Measure	Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone Individuals randomized into this group will only receive specialized therapy associated with this population.	Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
Overall Study STARTED	13	10
Overall Study COMPLETED	13	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Functional Electrical Stimulation (FES) in Persons Receiving Botulinum Neurotoxin for Upper Extremity Spasticity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone n=13 Participants Individuals randomized into this group will only receive specialized therapy associated with this population.	Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES n=10 Participants In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.	Total n=23 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	41.2 years STANDARD_DEVIATION 14.2 • n=5 Participants	54 years STANDARD_DEVIATION 10.3 • n=7 Participants	47.4 years STANDARD_DEVIATION 14.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	10 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: Per protocol. Number was determined based on the number of participants enrolled and eligible.

upper extremity function during activities of daily living based on observer ratings. Scale runs 0 (not used) to 5 (normal function). No subscales used.

Outcome measures

Outcome measures
Measure	FES and Repetitive Task Practice (RTP) n=10 Participants Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice	Repetitive Task Practice Alone n=13 Participants Individuals randomized to receive Repetitive Task Practice alone.
Change From Baseline in Arm Function Based on Motor Activities Log (MAL-O)	1.52 units on a scale Interval 0.63 to 2.4	1.79 units on a scale Interval 1.2 to 2.37

SECONDARY outcome

Timeframe: 12 weeks

Population: Per protocol.

Dextrous hand function measurement. Scale ranges from 0 (no dextrous arm function) to 57 (normal function)

Outcome measures

Outcome measures
Measure	FES and Repetitive Task Practice (RTP) n=10 Participants Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice	Repetitive Task Practice Alone n=13 Participants Individuals randomized to receive Repetitive Task Practice alone.
Change From Baseline in Dexterous Hand Function as Measured by the Action Research Arm Test (ARAT)	23.50 units on a scale Interval 8.83 to 38.17	31.40 units on a scale Interval 18.86 to 43.94

SECONDARY outcome

Timeframe: 12 weeks

Population: Per protocol

upper extremity function during activities of daily living as reported by the patient. Scale runs 0 (not used) to 5 (normal function). No subscales used.

Outcome measures

Outcome measures
Measure	FES and Repetitive Task Practice (RTP) n=10 Participants Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice	Repetitive Task Practice Alone n=13 Participants Individuals randomized to receive Repetitive Task Practice alone.
Change From Baseline in Self-performance in Activities of Daily Living Assessed With the (MAL - Self Report)	1.85 units on a scale Interval 0.86 to 2.84	1.71 units on a scale Interval 1.04 to 2.38

Adverse Events

Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES

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

Dr. Michael C. Munin

Department of Physical Medicine and Rehabilitation University of Pittsburgh

Phone: 412-648-6848

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place