Evaluation of a Tele-Rehabilitation Service Program

NCT ID: NCT02577276

Last Updated: 2018-06-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-06
• Study Completion Date: 2018-04-30

Brief Summary

Is a unique tele-rehabilitation service directed at treating upper limb weakness due to stroke feasible to provide at Mayo Clinic and are the individuals with stroke and the clinicians providing the care satisfied with the process?

Detailed Description

Participants will be identified from Mayo Clinic Division of Brain Rehabilitation's existing clinical practice and recruited either in person or by using a phone script.

Eligible participants will have 2 in-person clinical assessments, one before the intervention and one concluding the protocol. The first clinical assessment will involve introducing and familiarizing the participant with the study procedure, demonstrating and practicing with the system, and obtaining baseline clinical measures. During this first session the participant's technical skills and home equipment capabilities will be assessed and any assistance needed for establishing the technology in their home will be determined and provided. The second clinical assessment will include acquiring post-intervention clinical and outcome measures. Intervention duration will be 3 months. During the study period, each participant will receive online treatment for up to 45 minutes (in order to have net 30 min clinical time) twice per week. During these sessions, the clinician will teach system interaction including integrating feedback, instruct in system intervention activities and assure participant competence in system use, and adjust the level of difficulty in each activity according to the participant's abilities and needs. After the first month of intervention, the participant may be given permission by the therapist to train with the system for no more than 40 minutes per day. Such self-training opportunities are in addition to the twice weekly online sessions with the therapist.

Conditions

Stroke; Paresis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tele-motion rehabilitation system

Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.

Group Type: EXPERIMENTAL

Tele-motion rehabilitation system

Intervention Type: DEVICE

Tele-motion rehabilitation system: Interventions include functional therapeutic exercise and real-time feedback. Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.

Interventions

Tele-motion rehabilitation system

Tele-motion rehabilitation system: Interventions include functional therapeutic exercise and real-time feedback. Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.

Intervention Type: DEVICE

Other Intervention Names

Microsoft XB1 Kinect Sensor

Eligibility Criteria

Inclusion Criteria

• >12 months after stroke
• Age 21-80 years
• A minimum of 45 degrees of flexion in the affected shoulder
• Active extension of the affected elbow to 150 degrees
• Independent sitting balance
• Able to understand simple instructions
• Lives within a 100 mile radius and able to attend two clinical assessments at Mayo Clinic
• Able to install the tele-rehabilitation software with minimal remote technical support
• Available caregiver as needed who has basic technical understanding of computer operation
• i3 processor based PC; 26" monitor; Windows 7 or 8 operating system; Internet connection of at least 10Mbps.

Exclusion

• Medical conditions that may limit physical activity at the level of low intensity cardio-vascular exercise
• Any contraindication related to the integrity of the musculoskeletal system
• Active malignancy
• Uncontrolled epilepsy
• Global aphasia
• Severe apraxia
• Severe ataxia
• Unilateral spatial neglect
• Chronic pain
• Pregnancy
• Adults lacking capacity

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Gertner Institute

OTHER

Sponsor Role: collaborator

ReAbility Online

OTHER

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Allen Brown

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allen Brown, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

15-006308

Identifier Type: -

Identifier Source: org_study_id