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OpenTrials
Completed

NCT Number: NCT02577276

Evaluation of a Tele-Rehabilitation Service Program

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?

Completed

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Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Tele-motion rehabilitation system

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.

Other names: Microsoft XB1 Kinect Sensor

Primary outcomes

  1. Satisfaction Questionnaire

    Time frame: 3 months

    Clinician and participant satisfaction questionnaire

  2. System Usability Scale

    Time frame: 3 months

    Clinician and participant usability questionnaire

  3. Qualitative measure of technology/communications problems

    Time frame: 3 months

    Self report text of problems and difficulty with experimental technology and communication from participants and clinicians

Secondary outcomes

  1. Upper limb (shoulder, elbow) range of motion

    Time frame: Baseline and at 3 months

    Upper limb (shoulder, elbow) range of motion of the participant as measured by a goniometer

  2. Fugl- Meyer Scale

    Time frame: Baseline and at 3 months

    Fugl- Meyer Assessment for the participant's upper limb

  3. Motor Activity Log (MAL)

    Time frame: Baseline and at 3 months

    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.

  4. Measures from the ReAbility Online system of participant and clinician activity

    Time frame: Weekly through 3-month study period

    Time of practice by participant as measured by the ReAbility Online system

  5. Task performance scores

    Time frame: Weekly through 3-month study period

    Participant task performance scores as measured by the ReAbility Online system

  6. Upper limb range of motion

    Time frame: Weekly through 3-month study period

    Upper limb range of motion of participant as measured by the ReAbility Online system

  7. Number of compensatory movements

    Time frame: Weekly through 3-month study period

    Number of compensatory movements as measured by the ReAbility Online system

  8. Time online

    Time frame: Weekly through 3-month study period

    Time online of participant and clinician as measured by the ReAbility Online system

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • ReAbility Online
  • The Gertner Institute

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2015
Registry last updated
Jun 4, 2018

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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