Robotic and Conventional Hand Therapy After Stroke

NCT03020576 | Completed Results

• 1 other identifier: AAAI0093
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Impairment Based Arm Measures - Change in Upper Extremity Portion of the Fugl Meyer

  quantitative performance measure (scale ranging from 0 (minimum) to 66 (maximum) points) of arm and hand impairment. A higher score represents more skilled movements of the arm and hand.

  Through study completion, an average of 8 weeks (at baseline and at the 8-week completion point)

Secondary Outcomes (7)

• Change in Range of Motion Measures

  Through study completion, an average of 8 weeks

• Change in Hand and Pinch Strength

  Through study completion, an average of 8 weeks

• Change in Motor Activity Log Amount

  Through study completion (taken at baseline and at 8-week study completion)

• Change in Mobility and Activities of Daily Living

  Through study completion (taken at baseline and at 8 week study completion)

• Change in Hand Dexterity

  Through study completion, an average of 8 weeks

Study Arms (2)

Conventional Therapy

ACTIVE COMPARATOR

Participants randomized to this arm will receive conventional based therapy to their affected upper limb dose matched with the Robotic Therapy group. These interventions are aimed at increasing range of motion, strength and function at the shoulder, elbow, wrist and hand.

Other: Conventional Therapy

Robotic Therapy

EXPERIMENTAL

Participants randomized to this arm will receive robotic based therapy using the Amadeo Hand Robot device to improve range of motion, strength, and coordination to the wrist and hand.

Device: Amadeo Hand Robot Device

Interventions

Amadeo Hand Robot Device DEVICE

This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.

Robotic Therapy

Conventional Therapy OTHER

This arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand.

Conventional Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• history of stroke (\>3 months from time of ictus)
• paresis or plegia of the upper extremity.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Medical University Innsbruck: collaborator
• New York University: collaborator

Study Sites (2)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Innsbruck Medical University

Innsbruck, 6020, Austria

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Lauri Bishop, PT, DPT Research Physical Therapist
• Organization: Columbia University Medical Center/ Dept. of Rehabilitation & Regenerative Medicine

LB2413@cumc.columbia.edu

212-305-6095

Study Officials

• Joel Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Raimund Helbok, MD

  Innsbruck Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Rehabilitation and Regenerative Medicine Chair

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 13, 2017
• Study Start: April 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2016
• Last Updated: January 25, 2018
• Results First Posted: January 25, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); US (1)