Evaluation of a Tele-Rehabilitation Service Program

Stroke Clinical Trial

Official title:

Joint Gertner ReAbility Online and Mayo Clinic Feasibility Study: Evaluation of a Tele-Rehabilitation Service Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577276
• Other study ID #: 15-006308
• Status: Completed
• Phase: N/A
• Start date: November 6, 2016
• Est. completion date: April 2018

Study information

• Verified date: May 2018
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion

• >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

Related Conditions & MeSH terms

• Paresis
• Stroke

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Mayo Clinic	ReAbility Online, The Gertner Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Satisfaction Questionnaire	Clinician and participant satisfaction questionnaire	3 months
Primary	System Usability Scale	Clinician and participant usability questionnaire	3 months
Primary	Qualitative measure of technology/communications problems	Self report text of problems and difficulty with experimental technology and communication from participants and clinicians	3 months
Secondary	Upper limb (shoulder, elbow) range of motion	Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer	Baseline and at 3 months
Secondary	Fugl- Meyer Scale	Fugl- Meyer Assessment for the participant's upper limb	Baseline and at 3 months
Secondary	Motor Activity Log (MAL)	Individuals are asked to rate Quality of Movement (QOM) and Amount of Movement (AOM) during 30 daily functional tasks (original MAL), 28 functional tasks (MAL 28) or 14 tasks (MAL 14). Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting). Items scored on a 6-point ordinal scale.	Baseline and at 3 months
Secondary	Measures from the ReAbility Online system of participant and clinician activity	Time of practice by participant as measured by the ReAbility Online system	Weekly through 3-month study period
Secondary	Task performance scores	Participant task performance scores as measured by the ReAbility Online system	Weekly through 3-month study period
Secondary	Upper limb range of motion	Upper limb range of motion of participant as measured by the ReAbility Online system	Weekly through 3-month study period
Secondary	Number of compensatory movements	Number of compensatory movements as measured by the ReAbility Online system	Weekly through 3-month study period
Secondary	Time online	Time online of participant and clinician as measured by the ReAbility Online system	Weekly through 3-month study period