Dataset Information

Rehabilitation of Upper Extremity by Telerehabilitation Combined With Exergames in Survivors of Chronic Stroke: Preliminary Findings From a Feasibility Clinical Trial.

ABSTRACT:

Background

Exergames are increasingly being used among survivors of stroke with chronic upper extremity (UE) sequelae to continue exercising at home after discharge and maintain activity levels. The use of virtual reality exergames combined with a telerehabilitation app (VirTele) may be an interesting alternative to rehabilitate the UE sequelae in survivors of chronic stroke while allowing for ongoing monitoring with a clinician.

Objective

This study aimed to determine the feasibility of using VirTele in survivors of chronic stroke at home and explore the impact of VirTele on UE motor function, quantity and quality of use, quality of life, and motivation in survivors of chronic stroke compared with conventional therapy.

Methods

This study was a 2-arm feasibility clinical trial. Eligible participants were randomly allocated to an experimental group (receiving VirTele for 8 weeks) or a control group (receiving conventional therapy for 8 weeks). Feasibility was measured from the exergame and intervention logs completed by the clinician. Outcome measurements included the Fugl-Meyer Assessment-UE, Motor Activity Log-30, Stroke Impact Scale-16, and Treatment Self-Regulation Questionnaire-15, which were administered to both groups at four time points: time point 1 (T1; before starting the intervention), time point 2 (after the intervention), time point 3 (1 month after the intervention), and time point 4 (T4; 2 months after the intervention).

Results

A total of 11 survivors of stroke were randomized and allocated to an experimental or a control group. At the onset of the COVID-19 pandemic, participants pursued the allocated treatment for 3 months instead of 8 weeks. VirTele intervention dose was captured in terms of time spent on exergames, frequency of use of exergames, total number of successful repetitions, and frequency of videoconference sessions. Technical issues included the loss of passwords, internet issues, updates of the system, and problems with the avatar. Overall, most survivors of stroke found the technology easy to use and useful, except for 9% (1/11) of participants. For the Fugl-Meyer Assessment-UE and Motor Activity Log-30, both groups exhibited an improvement in >50% of the participants, which was maintained over time (from time point 3 to T4). Regarding Stroke Impact Scale-16 scores, the control group reported improvement in activities of daily life (3/5, 60%), hand function (5/5, 100%), and mobility (2/5, 40%), whereas the experimental group reported varied and inconclusive results (from T1 to T4). For the Treatment Self-Regulation Questionnaire-15, 75% (3/4) of the experimental group demonstrated an increase in the autonomous motivation score (from T1 to time point 2), whereas, in the control group, this improvement was observed in only 9% (1/11) of participants.

Conclusions

The VirTele intervention constitutes another therapeutic alternative, in addition to conventional therapy, to deliver an intense personalized rehabilitation program for survivors of chronic stroke with UE sequelae.

International registered report identifier (irrid)

RR2-10.2196/14629.

SUBMITTER: Allegue DR

PROVIDER: S-EPMC9260524 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveTo determine the extent to which estimates of sample and effect size in stroke rehabilitation trials can be affected by simple summation of ordinal Upper Extremity Fugl-Meyer (UEFM) items compared with a Rasch-rescaled UEFM.DesignRasch analysis of Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) phase III trial data, comparing 3 upper extremity (UE) motor treatments in stroke survivors enrolled 45.8±22.4 days poststroke. Participants underwent a structured UE motor training known as the Accelerated Skill Acquisition Program, usual and customary care, or dose-equivalent care. UEFM data from baseline, postintervention, and 6 and 12 months later were included for analysis.SettingOutpatient stroke rehabilitation.ParticipantsICARE participants (N=361).InterventionsNot applicable.Main outcome measuresItem difficulties, person abilities, and sample size.ResultsBecause of their ordinality, summed raw UEFM scores measured motor impairment inconsistently across different ranges of stroke severity relative to the rescaled UEFM. In the full ICARE sample, raw UEFM understated scores relative to the rescaled UEFM by 7.4 points for the most severely impaired, but overstated scores by up to 8.4 points toward the ceiling. As a result, 50.9% of all UEFM observations showed a residual error greater than 10% of the total UEFM score. Relative to the raw scores, the rescaled UEFM improved the effect size of change in motor impairment between baseline and 1 year (d=0.35). For a hypothetical 3-arm trial resembling ICARE, UEFM rescaling reduced the required sample size by 32% (n=108) compared with raw UEFM (n=159).ConclusionsIn UE rehabilitation trials, a rescaled UEFM potentially decreases sample size by one-third, decreasing costs, duration, and the number of subjects exposed to experimental risks. This benefit is obtained through increased measurement efficiency. Reductions in ceiling effects are also possible. These findings apply to ICARE-like trials. Confirmatory validation in another phase III trial is needed.

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