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Treatment of Hand Dysfunction After Stroke

Treatment of Hand Dysfunction After Stroke

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00508521
Enrollment
4
Registered
2007-07-30
Start date
2007-01-31
Completion date
2010-06-30
Last updated
2014-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

cerebrovascular accident, electrical stimulation, motor learning, upper extremity rehabilitation

Brief summary

Many stroke survivors exhibit persistent upper limb motor deficits and a non-functional upper limb. There is some promising information that suggests motor learning (ML) in conjunction with functional electrical stimulation (FES; surface FES; nothing implanted; use of a commercially available system) of wrist/finger muscles can significantly enhance the functional level of the upper limb. There have been promising studies showing that some subjects in the chronic phase (greater than 6 months after stroke) responded favorably to combination FES and ML (FES ML). In our pilot studies, FES ML for those in the chronic phase (\>12 months) produced statistically significant functional recovery. FES was applied using a commercially available, two-channel FES system, with electrodes applied to the surface of the skin (non-invasive). But if upper limb dysfunction is not immediately treated, that is within the sub-acute phase (less than 6 months) following stroke, the following problems can develop: contractures and other soft tissue changes; chronic pain; and ingrained, abnormal, non-functional movement patterns. The more long-standing these symptoms are, the more resistant to treatment they become. Therefore, it is important to provide promising interventions prior to the onset of chronic symptoms and dysfunction. Those in the sub-acute phase after stroke should be provided with FES ML, in order to more completely restore function for a greater number of stroke survivors. Specific Aims and Hypotheses The goal of this pilot study is to test the feasibility of the proposed treatment in the sub acute phase following stroke. HYPOTHESIS. FES ML for 3hrs/day, five days/week, for 12 weeks will be feasible to implement in the sub-acute phase following stroke (2 -24 weeks). Study Design a. Specific Procedures This is a pilot study to test the feasibility of using FES ML for upper extremity rehabilitation in a sub-acute stroke population. It is a randomized, controlled, single-blind design. Subjects will be 2 - 24 weeks after a single stroke. The control group will receive standard care for upper limb rehabilitation consisting of passive and active exercise, stretching, bracing, and use of adaptive devices. The experimental group will receive the experimental intervention in addition to their standard care. CONTROL GROUP INTERVENTION. The control group will receive the standard medical care prescribed by the primary physician and covered by the subject's health care policy. Standard care will include: soft tissue mobilization; assisted motion exercise; active motion exercise; resistive exercise; task practice; use of assistive devices; and modality applications conventionally prescribed. FES ML INTERVENTION. The research treatment duration will be 3hrs/day, five days per week. The subjects will be present for a fourth hour each day, which will be used for breaks and rest periods that will be interspersed throughout the intervention time. The treatment duration is derived from prior work. We will stimulate muscles in a number of configurations including: wrist extension and finger extension; wrist extension and finger flexion; and wrist extension, finger flexion, and thumb abduction and opposition. Motor learning will include the performance of functional task components and full task practice during the use of FES. FES will be triggered by the patient, the treating therapist, or it will be automatically sequenced by the device according to alternate channel activations, with timings pre-set by the treating therapist. MEASURES. Data will be collected at weeks 1, 6, 12 (end of treatment), and 6 months after the end of treatment. Population The subjects will be sub-acute stroke survivors (2-24 weeks after stroke).

Interventions

DEVICEFunctional Electrical Stimulation

commercially available surface electrical stimulator

OTHERStandard Care

Standard care as ordered by their physician and covered by their insurance company.

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 2-24 weeks after stroke * Greater than 21 years old * Ability to follow 2 step commands

Exclusion criteria

* Chronic, progressive medical condition (i.e. Parkinson's Disease)

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer Upper Limb Coordination Scale (FMUE)baseline and after 12 weeks of trainingA 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.

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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

Participants by arm

ArmCount
Arm 1 Subjects With Acute Stroke
Subjects \< 6 months following first stroke who had diminished upper limb strength, coordination and function.
4
Total4

Baseline characteristics

CharacteristicArm 1 Subjects With Acute Stroke
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
Region of Enrollment
United States
4 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
2 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 4
serious
Total, serious adverse events
0 / 4

Outcome results

Primary

Fugl-Meyer Upper Limb Coordination Scale (FMUE)

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.

Time frame: baseline and after 12 weeks of training

ArmMeasureGroupValue (MEAN)Dispersion
Arm 1 Subjects With Acute StrokeFugl-Meyer Upper Limb Coordination Scale (FMUE)Pre-Treatment Fugl Meyer Upper Limb Score27.75 units on a scaleStandard Deviation 3.86
Arm 1 Subjects With Acute StrokeFugl-Meyer Upper Limb Coordination Scale (FMUE)Post-Treatment Fugl Meyer Upper Limb Score48.50 units on a scaleStandard Deviation 3.16
Comparison: This was a feasibility study. Pre and post treatment analysis was performed for the study participants.p-value: 0.000195% CI: [-22.27348, -19.22652]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026