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OpenTrials
Completed

NCT Number: NCT00435617

Study of Hand Therapy 3 to 24 Months After Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University, College of Nursing & Healthcare Innovation, Phoenix, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hand Mentor

Device

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.

Other names: Hand Mentor Home

Primary outcomes

  1. Wolf Motor Function Test

    Time frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks

Secondary outcomes

  1. Compliance with recommended use

    Time frame: 6 wks, 12 wks

  2. Fugl-Meyer Test

    Time frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks

  3. Stoke Impact Scale

    Time frame: Initial, 6 wks, 12 wks, 16 wks, 52 wks

Sponsors and collaborators

Lead sponsor

Kinetic Muscles

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Clinical Assessment of a Massed Practice Therapy Device

Important dates

Study start
2005
Primary completion
2009
Study completion
2010
First posted
Feb 15, 2007
Registry last updated
Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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