Trial Outcomes & Findings for Evaluation of Robotic Arm Rehabilitation in Stroke Patients (NCT NCT00333983)

Last Updated: 2014-03-20

Results Overview

The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

62 participants

Primary outcome timeframe

Baseline to Final Training (6 weeks)

Results posted on

2014-03-20

Participant Flow

147 community-dwelling adults with a diagnosis of chronic stroke were referred for study criteria screening by local VA stroke clinics and PT/OT clinicians. Community study advertisements and flyers were also utulized during this recruitment period that started October 2006 and ended December 2009.

Participants were excluded prior to randomization if they did not meet inclusion/exclusion criteria. Some candidates declined after learning of the study length and schedule committment.

Participant milestones

Participant milestones
Measure	Planar Robot Robot-assisted planar reaching x 60 minutes	Planar + Vertical Robot Robot-assisted planar and robot-assisted vertical reaching x 60 minutes	Intensive Conventional Exercise Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes.
Overall Study STARTED	20	21	21
Overall Study COMPLETED	17	16	19
Overall Study NOT COMPLETED	3	5	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Planar Robot Robot-assisted planar reaching x 60 minutes	Planar + Vertical Robot Robot-assisted planar and robot-assisted vertical reaching x 60 minutes	Intensive Conventional Exercise Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes.
Overall Study Lost to Follow-up	2	1	0
Overall Study Adverse Event	1	1	1
Overall Study Withdrawal by Subject	0	3	1

Baseline Characteristics

Evaluation of Robotic Arm Rehabilitation in Stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Planar Robot n=20 Participants Robot-assisted planar reaching x 60 minutes.	Planar + Vertical Robot n=21 Participants Robot-assisted planar and robot-assisted vertical reaching x 60 minutes.	Intensive Conventional Exercise n=21 Participants Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.	Total n=62 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	52 Participants n=4 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	10 Participants n=4 Participants
Age, Continuous	57 years STANDARD_DEVIATION 12 • n=5 Participants	60 years STANDARD_DEVIATION 13 • n=7 Participants	56 years STANDARD_DEVIATION 6.3 • n=5 Participants	57 years STANDARD_DEVIATION 11 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	11 Participants n=5 Participants	28 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	34 Participants n=4 Participants
Region of Enrollment United States	20 participants n=5 Participants	21 participants n=7 Participants	21 participants n=5 Participants	62 participants n=4 Participants
Fugl-Meyer Upper Extremity Motor Assessment	20.3 units on a scale STANDARD_DEVIATION 14.7 • n=5 Participants	16.5 units on a scale STANDARD_DEVIATION 10.6 • n=7 Participants	18.2 units on a scale STANDARD_DEVIATION 12.5 • n=5 Participants	18.0 units on a scale STANDARD_DEVIATION 12.5 • n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Final Training (6 weeks)

Population: The number of participants analyzed were based on an intention to treat methodology with the exception of individuals that were non-compliant with the protocol or did not progress to the midpoint (3 week) evaluation.

Outcome measures

Outcome measures
Measure	Planar Robot n=20 Participants Planar Robot Exercise x 60 minutes.	Planar + Vertical n=21 Participants Planar + Vertical Robot Exercise x 60 minutes.	Intensive Conventional Exercise n=21 Participants Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment	3.27 units on a scale Standard Deviation 3.27	2.51 units on a scale Standard Deviation 3.33	1.82 units on a scale Standard Deviation 4.24

Adverse Events

Planar Robot

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Planar + Vertical Robot

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Intensive Conventional Exercise

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Planar Robot n=20 participants at risk Planar Robot Exercise Group	Planar + Vertical Robot n=21 participants at risk Planar + Vertical Robot Exercise Group	Intensive Conventional Exercise n=21 participants at risk Upper extremity stretching, skateboard reaching activities, range of motion and arm ergometer training.
General disorders Hospitalization	10.0% 2/20 • Number of events 2 • Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.	4.8% 1/21 • Number of events 1 • Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.	0.00% 0/21 • Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.
Musculoskeletal and connective tissue disorders Shoulder pain	0.00% 0/20 • Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.	0.00% 0/21 • Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.	4.8% 1/21 • Number of events 1 • Adverse event data was collected over a 6 month time period for each participant which included baseline testing, intervention and retention.

Additional Information

Dr. Susan S. Conroy

VA Maryland Health Care System, Baltimore

Phone: (410) 605-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place