Phase 2 N=21 Randomized Single-blind Treatment

Treatments for Recovery of Hand Function in Acute Stroke Survivors

Stroke, Acute · Stroke · Hemiparesis · Hemiplegia

Bottom Line

View on ClinicalTrials.gov: NCT00565045 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment) — -11.6; -43.4 degrees

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Neuromuscular electrical stimulator (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: MetroHealth Medical Center
Primary completion: Apr 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Voluntary Finger Extension Angle (a Measure of Hand Impairment)	-11.6; -43.4	—
SECONDARY Finger Tracking Error	4.7; 8.3	—
SECONDARY Box and Blocks Score	29.8; 22.9	—
SECONDARY Arm Motor Abilities Test	3.54; 3.20	—
SECONDARY Fugl-Meyer Assessment (Upper Extremity)	46.2; 41.1	—

Summary

Impaired hand function is one of the most frequently persisting consequences of stroke. The purpose of this study is to investigate whether two different types of treatment improve recovery of hand function after stroke.

Eligibility Criteria

Inclusion Criteria

Age 18 to 80
Within 6 months of first clinical hemorrhagic or nonhemorrhagic stroke
Cortical or subcortical stroke
Unilateral upper extremity hemiparesis with severe finger extensor and flexor paresis ( = 13 on Beck Depression Inventory Fast Screen)
Ipsilateral lower motor neuron lesion
Parkinson's Disease
Spinal cord injury
Traumatic brain injury
Multiple sclerosis
Lack of functional passive range of motion of the wrist or fingers of affected side
Severe shoulder or hand pain (unable to volitionally position hand in the workspace without pain)
Intramuscular botulinum toxin injections in upper extremity muscle in the last 3 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00565045). 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.