Translating Intensive Arm Rehabilitation in Stroke to a Telerehabilitation Format

NCT02665052 | Completed Results DMC FDA Device

• 1 other identifier: B1828-R
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Hemiparesis

Keywords

Rehabilitation; Motor Recovery; upper extremity

Outcome Measures

Primary Outcomes (1)

• Wolf Motor Function Test Performance Time (WMFT)

  The change between WMFT performance time from baseline to post-training was analyzed. Change = 6week WMFT log (time) minus baseline WMFT log (time). The WMFT performance time is a measure of movement speed to complete fifteen timed tasks up to a maximum of 120 seconds. A faster time (lower value) indicates a better outcome. The WMFT logarithm transformed time (WMFT log (time)) mean values were analyzed to reduce the skewness of the WMFT time values. The primary study outcome was the between group difference in the Home-based WMFT log (time) post-training compared to the control.

  Final Training (week 6)

Secondary Outcomes (2)

• Fugl-Meyer Assessment Scale-Upper Extremity

  Final Training (week 6)

• Stroke Impact Scale (SIS)-Hand Domain

  Final Training (week 6)

Study Arms (3)

Home-Based BATRAC

EXPERIMENTAL

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.

Device: Home-Based BATRAC plus TTT

Lab-based BATRAC plus TTT

EXPERIMENTAL

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).

Device: Lab-based BATRAC plus TTT

Delayed Entry Usual Care

PLACEBO COMPARATOR

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.

Behavioral: Delayed Entry Usual Care

Interventions

Home-Based BATRAC plus TTT 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.

Home-Based BATRAC

Lab-based BATRAC plus TTT 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.

Lab-based BATRAC plus TTT

Delayed Entry Usual Care 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.

Delayed Entry Usual Care

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

Related Publications (2)

• 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.

  PMID: 33336184 DERIVED

• 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.

  PMID: 32869689 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Previous VA guidance restricted MyHealtheVet (MHV) patient portal secure messaging (SM) from research making this study its first expansion as a tele-rehabilitation research tool. Several challenges related to equipment procurement and finalization of MHV patient portal research guidelines affected the recruitment timeline resulting in a small sample size. Therefore, the analysis of the primary outcome measure, a change from baseline to week 6 in Wolf performance time was underpowered.

Results Point of Contact

• Title: Dr. Susan S. Conroy
• Organization: Baltimore VA Medical Center VA Maryland Health Care System

susan.conroy@va.gov

(410) 637-3213

Study Officials

• Susan S Conroy, DSc PT

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded evaluator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Parallel: participants are randomized to one of 3 groups: delayed control, active clinic-based training or active home-based training for the initial phase of the study. The delay group is randomly assigned to receive either clinic-based or home-based training for the second phase of the study.

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: May 1, 2017
• Primary Completion: January 16, 2020
• Study Completion: January 16, 2020
• Last Updated: March 17, 2021
• Results First Posted: March 17, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)