N/A N=10 Randomized Single-blind Treatment

Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT02747433 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2020

Primary outcome: Primary: Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest — 11.0; 2.0; 8.5 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Robot-Assisted Therapy (RT) (Device); Robot & Task-Oriented Training (RT-TOT) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Spaulding Rehabilitation Hospital
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Fugl-Meyer Assessment (FMA) - Upper Extremity Subtest	11.0; 2.0; 8.5	—
PRIMARY Change From Baseline in Wolf Motor Function Test (WMFT)	10.22; 3.07; 6.98	—
PRIMARY Change From Baseline on Confidence in Arm and Hand Movement (CAHM) Scale	8.00; 9.50; 8.75	—
SECONDARY Change From Baseline on Motor Activity Log (MAL) - Amount of Use (AOU) Scale	0.89; 0.52; 0.59	—
SECONDARY Change From Baseline on Motor Activity Log (MAL) - How Well (HW) Scale	1.00; 0.71; 0.81	—
SECONDARY Change From Baseline on Modified Ashworth Scale (MAS)	0.00; 0.22; 0.03	—
SECONDARY Change From Baseline on Stroke Impact Scale (SIS) - Hand Domain	8.00; 4.00; 4.00	—
SECONDARY Change From Baseline on Stroke Impact Scale (SIS) - Percent Recovery	20.00; 5.00; 10.00	—
SECONDARY Change From Baseline in Movement Time During Reach-to-Target Task	2.37; 2.17	—
SECONDARY Change From Baseline in Log Dimensionless Jerk During Reach-to-Target Task	-18.89; -18.14	—

Summary

Stroke is the leading cause of long-term disability in older adults in the United States. At six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke each year continue to have motor impairments that inhibit functional use of the weaker arm during daily activities and negatively impact quality of life. Rehabilitation robots provide clinicians with new treatment options to improve movement and arm function after stroke. The purpose of this pilot study is to develop and test a therapy called the "Active Learning Program for Stroke" (ALPS). We are combining this therapy program with robot-assisted therapy and a home program for the stroke-affected arm and hand.

Eligibility Criteria

Inclusion Criteria

Moderate UE hemiparesis (i.e. some ability to move shoulder, elbow & hand and initial score on the Fugl-Meyer Assessment (FMA) between 21-50/66))
Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score >/=26/30)12 during initial evaluation visit

Exclusion Criteria

No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy
Increased muscle tone as indicated by score of >/= 3 on the Modified Ashworth Scale;
Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test 13
Aphasia sufficient to limit comprehension and completion of the treatment protocol
Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02747433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.