N/A
N=31
Robotic and Conventional Hand Therapy After Stroke
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03020576 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer — 5.9; 2.1 change in units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amadeo Hand Robot Device (Device); Conventional Therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer |
5.9; 2.1 | — |
| SECONDARY Change in Range of Motion Measures |
3.53; 3.33 | — |
| SECONDARY Change in Hand and Pinch Strength |
1.63; 0.84 | — |
| SECONDARY Change in Motor Activity Log Amount |
9.35; 2.53 | — |
| SECONDARY Change in Mobility and Activities of Daily Living |
6.78; -0.36 | — |
| SECONDARY Change in Hand Dexterity |
10.67; -1.12 | — |
| SECONDARY Change in Spasticity Measures |
-0.10; -0.10 | — |
| SECONDARY Change in Motor Activity Log How Well |
12.79; 2.6 | — |
Summary
Weakness is a major cause of disability in stroke survivors. Rehabilitation techniques are often not effective in restoring full function of the upper limb. Specifically, many individuals remain with weakness in the hand, preventing its return to full use.
Robotic therapies have been developed as exercise tools for stroke survivors. Devices, such as the InMotion2, have been shown to be useful in restoring some motor function in the upper limb. However, most existing devices designed to be used with the upper limb have primarily been developed to treat the shoulder, elbow and wrist. They have not specifically addressed hand function.
Tyromotion, Inc. has developed the Amadeo, which is primarily intended to provide rehabilitation for patients with neurological or orthopedic deficits in hand function. Initial clinical testing has demonstrated the practicality of using this device in a population of stroke survivors, although further research is needed to better understand the usefulness of the Amadeo device as compared with conventional rehabilitation methods. The purpose of this study was to compare results of training with the Amadeo device or training with conventional therapies.
A total of 28 subjects from two separate sites participated in the study and underwent baseline testing of upper limb motor and sensory performance and function. Subjects were then assigned to one of two treatment groups with a 50:50 chance of being in either group. One group underwent training with the Amadeo device and the other group underwent training with conventional therapy. All training sessions were 60 minutes in duration, three days/week for eight weeks (24 total sessions). Subjects were reassessed on completion of the training program.
Eligibility Criteria
Inclusion Criteria
- history of stroke (>3 months from time of ictus)
- paresis or plegia of the upper extremity.
Exclusion Criteria
- severe spasticity (defined on the Ashworth Scale with a score of 4-5)
- severe pain despite conventional pain therapy of the paretic upper extremity
- swelling, infection, fracture or ulcers of the paretic extremity
- arthritis of the hand joints
- pregnant
- botulinum toxin- therapy to the upper extremity within 3 months prior to study entry
- severe contractions
Data sourced from ClinicalTrials.gov (NCT03020576). 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.