NCT03460587

Long-term Telerehabilitation for Patients With Stroke

Completed NA Results posted Last updated 17 December 2020

What this trial tests

NA trial testing Telerehabilitation in Stroke in 13 participants. Completed in 31 March 2019.

Timeline

29 August 2018

Primary endpoint
31 March 2019

31 March 2019

Quick facts

Lead sponsor	University of California, Irvine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	13
Start date	29 August 2018
Primary completion	31 March 2019
Estimated completion	31 March 2019
Sites	1 location across United States

Drugs / interventions tested

• Telerehabilitation

Conditions studied

• Stroke — all drugs for Stroke →
• Cerebrovascular Disorders — all drugs for Cerebrovascular Disorders →
• Brain Diseases — all drugs for Brain Diseases →
• Central Nervous System Diseases — all drugs for Central Nervous System Diseases →

Sponsor

University of California, Irvine

Who can join

18 and older, any sex, with Stroke or Cerebrovascular Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Fugl-Meyer Arm Motor Scale Primary · 90 days

measure of arm impairment, scores range from 0 to 66 with higher numbers reflecting less arm impairment

Group	Value	95% CI
Home-based Telerehabilitation	59	52.5 – 61.5

Fugl-Meyer Leg Motor Scale Secondary · 90 days

measure of leg impairment, scores range from 0 to 34 with higher numbers reflecting less leg impairment

Group	Value	95% CI
Home-based Telerehabilitation	28	27 – 30.5

Sponsor's own description

The aim of the current protocol is to study 40 patients, each for 12 weeks, to address hypotheses related to the ability of a telerehabilitation system to (a) improve motor status and disability, (b) collect various forms of patient data from the home, (c) improve risk factor knowledge and control, and (d) assess patient compliance with home-based telerehabilitation.

Patients who have returned to their home after stroke will be provided with a telehealth system and be asked to use it 6 days/week for 12 weeks, during which time subjects will use this system for daily rehabilitation therapy, assessments, and education--all on one platform.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A Feasibility Study of Expanded Home-Based Telerehabilitation After Stroke.
   Cramer SC, Dodakian L, Le V, McKenzie A, et al · · 2020 · cited 30× · PMID 33613417 · DOI 10.3389/fneur.2020.611453