Study of Hand Therapy 3 to 24 Months After Stroke

K

Kinetic Muscles

Status

Completed

Conditions

Cerebrovascular Accident

Treatments

Device: Hand Mentor

Study type

Interventional

Funder types

Industry
NIH

Identifiers

NCT00435617
R44HD041805 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

78 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

78 participants in 1 patient group

A
Experimental group
Description:
Hand Mentor
Treatment:
Device: Hand Mentor

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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