Translating Intensive Arm Rehabilitation in Stroke to a Telerehabilitation Format

NCT ID: NCT02665052

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2020-01-16

Brief Summary

Loss of arm use and strength are common problems after stroke that greatly affects independence in activities of daily living. Arm rehabilitation using robot-assisted repetitive task training has shown to improve motor recovery. However, this type of exercise cannot be done at home as these devices are large and expensive. This study will test whether a more portable, less costly, non-robotic repetitive training device called Bilateral Arm Training with Rhythmic Auditory Cuing (BATRAC) performed at home with a tele-rehabilitation format will lead to improvement in arm and hand use in patients with chronic stroke. The investigators plan to test the effectiveness of home based tele-rehabilitation with the BATRAC compared to a home and a clinic based approach.

Detailed Description

This is a longitudinal, single blind, randomized controlled trial with three parallel 6 week intervention arms that will be conducted over a three-year time period. After obtaining informed consent, and completing baseline testing, participants will be randomized to one of three study arms: 1) Home-based BATRAC Telerehab (HBT) + TTT, 2) Lab-based BATRAC (LBB) + TTT, and 3) Delayed Entry Usual Care. This delayed entry group will serve as a control for the initial six weeks of enrollment and NOT receive an active study intervention before randomizing to one of the two active interventions. Weekly phone calls will be conducted during this control period to record general activity (household or community) and monitor amount and intensity of arm use.

Participants will complete Home-based BATRAC training or Lab-based BATRAC training three times a week for 6-9 weeks for a total of 18 training sessions. Participants will then be asked to return for a follow-up after 8 weeks of no training. A study evaluator blinded to the intervention assignment will complete all outcome measures at baseline, training completion, and at the 8 week retention follow-up. The participants in the Home-based BATRAC telerehabilitation group will be given a VA's MyHealtheVet (www.myhealth.va.gov) website account for asynchronous communication with the therapist and to access the educational features and resources about stroke, exercise and caregiver support. The interventions are as described below.

1. Home-based BATRAC telerehabilitation: The BATRAC training platform will be used in conjunction with the VA MyHealtheVet website. This group will have a MyHealtheVet account to access the Secure Messaging Option for VA approved electronic messaging to the study therapist. The MyHealtheVet will provide asynchronous communication with the study therapist, and will store performance information entered by the participant and caregiver related to arm exercise duration, repetitions completed and distances reached. This account can be securely linked and is VA approved for use on any home device (computer, cell phone or tablet) with internet. MyHealtheVet training will be completed at the VA and at a one-time home visit with the participant and their identified caregiver to verify access, and use.

BATRAC training will consist of 45 minutes of high intensity bilateral reaching and rest periods (see Lab-based BATRAC training details below) followed by 15 minutes of video guided Transition to Task Training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos demonstrating the exercise. The initial training will occur in the lab setting with the therapist for BATRAC instruction and TTT exercise training. The participant and caregiver will have the opportunity ask questions and develop proficiency during this training session. For the TTT, each functional task will be presented via the MyHealtheVet Secure Messaging (SM) and linked by a URL to an instructive Youtube video clip of exercise sequencing, and level of difficulty. After completion of each exercise session the participant will complete a study report form attached to the SM. This information will be available for off-line assessment of performance by the research therapist. In cases of participant non-adherence, the therapist can contact the participant via phone to review exercise barriers and motivate the individual to participate. If necessary, the therapist could change the exercise parameters and send changes within the My HealtheVet SM.

2. Lab-based BATRAC + TTT training: Participants randomized to this group will receive 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). The BATRAC training consists of high intensity bilateral reaching and retrieving (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. The track can be set at different angles in the work space. The training protocol is the same for both groups and will consist of four, 5-minute periods interspersed with 5-minute rest periods to avoid fatigue. An auditory metronome is set initially at the participant's preferred speed and for periods 1 and 3 participants move both arms simultaneously (in-phase). In periods 2 and 4 participants move both arms in alternating (antiphase) movements. A fifth bout of simultaneous arm movements will be included to reach the 45 minute training goal. Progression of the auditory cue frequency, direction of travel (pushing/pulling or in a diagonal) and distance of reach will be progressed every 2 weeks based on performance. If a progression cannot be sustained for the five-minute bouts by the end of the session, adjustments towards the previous level are made. This training will be followed by 15 minutes of transition to task training (TTT) as described below with supervision and support as needed by the therapist.

Transition to Task Training (TTT): Each participant will receive 45 minutes of their randomized BATRAC intervention followed by 15 minutes of TTT. This training is functionally based in four domains of real-world tasks: homemaking, hygiene, feeding, and dressing. Two goal directed functional tasks are selected from the four domains every two weeks and prescribed to the individual based on severity level, general interests and goal. The task design is progressive in nature and difficulty is added by changing the parameters (movement amplitude) and demand (resistance) for increased generalization to real life challenges. Assist by the therapist or caregiver is provided to prevent compensatory movements from being re-enforced. For the home-based training, the caregiver will be instructed to provide this assistance through the initial personal training as well as have access to a set of videos for each of the tasks.

3. Delayed Entry Usual Care: Participants randomized to this group will initially serve as a control and not receive any study interventions except for the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level. After serving as a control, this group will be entered into their delayed active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.

Conditions

Stroke; Hemiparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Home-Based BATRAC

Home-based BATRAC training will consist of 45 minutes of high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system.

Group Type: EXPERIMENTAL

Home-Based BATRAC plus TTT

Intervention Type: DEVICE

Home-based BATRAC training will consist of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT) using the BATRAC training will include high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system.

Lab-based BATRAC plus TTT

Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and rest periods followed by 15 minutes of therapist guided transition to task training (TTT).

Group Type: EXPERIMENTAL

Lab-based BATRAC plus TTT

Intervention Type: DEVICE

Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and retrieving actions (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. This training will be followed by 15 minutes of transition to task training (TTT) with supervision and support as needed by the therapist.

Delayed Entry Usual Care

Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions. They will also receive weekly phone calls to record general activity level. After serving as a control, this group will be entered into their randomized active intervention group of either lab-based BATRAC + TTT training, or Lab-based Robot+ TTT.

Group Type: PLACEBO_COMPARATOR

Delayed Entry Usual Care

Intervention Type: BEHAVIORAL

Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level.

Interventions

Home-Based BATRAC plus TTT

Home-based BATRAC training will consist of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT) using the BATRAC training will include high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system.

Intervention Type: DEVICE

Lab-based BATRAC plus TTT

Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and retrieving actions (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. This training will be followed by 15 minutes of transition to task training (TTT) with supervision and support as needed by the therapist.

Intervention Type: DEVICE

Delayed Entry Usual Care

Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18 years or older
• Have a clinically defined unilateral hemiparetic stroke with radiologic exclusion of other diagnosis
• Stroke onset of at least 6 months prior to enrollment
• Present with moderate to severe arm impairment based on a Fugl-Meyer score ranging from 19-50 out of 66
• No previous experience using the BATRAC
• Ability to use and interact with the tele-rehabilitation platform according to study protocol
• Have an identified individual/caregiver to perform the TTT exercises if randomized to the Home Telerehabilitation group

Exclusion Criteria

• Musculoskeletal diagnosis or significant arm pain that would interfere with positioning and use of the intervention (BATRAC) devices
• Cognitive impairment such that the participant is unable to understand the study requirements to answer the Evaluation to Sign Consent Form tool accurately
• Absence of a working telephone line or cell phone for telerehabilitation set-up if randomized to this group
• Enrollment in a concurrent rehabilitation study or actively receiving therapy for their stroke affected (study) arm
• Having received a botulinum toxin injection to the stroke affected (study) arm within 3 months of enrollment

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Susan S Conroy, DSc PT

Role: PRINCIPAL_INVESTIGATOR

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Locations

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States

Countries

United States

References

Bhatnagar K, Bever CT, Tian J, Zhan M, Conroy SS. Comparing Home Upper Extremity Activity with Clinical Evaluations of Arm Function in Chronic Stroke. Arch Rehabil Res Clin Transl. 2020 Jun 18;2(2):100048. doi: 10.1016/j.arrct.2020.100048.

Reference Type: DERIVED

PMID: 33336184 (View on PubMed)

Conroy SS, Harcum S, Keldsen L, Bever CT Jr. Novel use of existing technology: A preliminary study of patient portal use for telerehabilitation. J Telemed Telecare. 2022 Jun;28(5):380-388. doi: 10.1177/1357633X20950172. Epub 2020 Sep 1.

Reference Type: DERIVED

PMID: 32869689 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

B1828-R

Identifier Type: -

Identifier Source: org_study_id