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Study of Hand Therapy 3 to 24 Months After Stroke

Clinical Assessment of a Massed Practice Therapy Device

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00435617
Enrollment
78
Registered
2007-02-15
Start date
2005-05-31
Completion date
2010-05-31
Last updated
2012-07-20

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

Conditions

Cerebrovascular Accident

Keywords

stroke rehabilitation, stroke therapy, hand therapy, stroke, cerebrovascular stroke, cerebral stroke

Brief summary

The primary aim of this study is to investigate the effectiveness of the use of a robotic hand therapy device in the home environment. We hypothesize that the therapy group will improve hand function more than a customary and usual care group.

Detailed description

Many stroke survivors have significant limitations of upper extremity function which impacts many important activities such as eating, dressing and personal care. Studies show that to be effective in increasing functional independence, therapy must involve active participation of the patient and repetitive training. Robotic therapy offers a means of transferring some of this essential, but time consuming, therapy into the home. Seventy subjects (3 to 12 months post stroke)are being randomized to a control group that utilizes an innovative robotic hand therapy device in the home for three months or a control group that receives no device treatment. Clinical motor function and quality of life measures will compare the groups before intervention, immediately after, and 3 months later. The control group will receive device treatment for 3 months following their final evaluation. The results will provide valuable data on the ability of monitored home therapy to provide effective treatment. This project has the potential to increase the availability of effective rehabilitation techniques to patients with stroke.

Interventions

DEVICEHand Mentor

Use of the Hand Mentor therapy device at home for 6 weeks. Therapy programs include spasticity reduction, motor control, and emg biofeedback for encouraging activity.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
Kinetic Muscles
Lead SponsorINDUSTRY

Study design

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* 3 to 24 months post stroke * Able to extend wrist and fingers at least 10 degrees * Functional hearing and vision * Able to follow instructions * Lives at home, not institution * Stable medications for 3 months

Exclusion criteria

* Excessive cognitive impairments * Taking/Receiving medicines/shots to make arm/hand less stiff * Severe pain in the impaired arm * Stroke was more than 24 months ago

Design outcomes

Primary

MeasureTime frame
Wolf Motor Function TestInitial, 6 wks, 12 wks, 16 wks, 52 wks

Secondary

MeasureTime frame
Compliance with recommended use6 wks, 12 wks
Fugl-Meyer TestInitial, 6 wks, 12 wks, 16 wks, 52 wks
Stoke Impact ScaleInitial, 6 wks, 12 wks, 16 wks, 52 wks

Countries

United States

Outcome results

None listed

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