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Tele-reha Versus Paper-based Aftercare Programme Following Inpatient Rehabilitation

NCT ID: NCT05940584

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-14

Study Completion Date

2025-01-14

Brief Summary

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The goal of this three-armed, observer-blinded, randomised controlled trial is to (i) to implement a telerehabilitation intervention in routine care after an inpatient rehabilitation stay for people insured with the Social Insurance Institution for the Self-Employed (SVS), (ii) to evaluate the impact of telerehabilitation on the consolidation of goals achieved during the inpatient stay in everyday life, and (iii) to evaluate whether independence in everyday life can be increased by implementing telerehabilitation at home compared to standard care. Our hypothesis is that the tele-reha intervention, including ongoing therapist support, will improve independence in daily living (defined as the primary outcome of this study), as measured by the Functional Assessment Measure (FAM), compared to a control group receiving a standard paper-based program.

Detailed Description

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All patients admitted to the NRZ receive a Baseline Assessment (T0). Rehabilitation aims are defined based on symptoms, functional limitations and participation restrictions, and routine care is provided accordingly. At discharge, patients undergo another assessment to determine if the rehabilitation aims have been reached (Post-inpatient Evaluation \[T1\]). Between T0 and T1, patients participating in this study will be randomly assigned to either a tele-reha group (Intervention Group) or a control group (Control Group 1) stratified for the likelihood of a positive rehabilitation outcome (determined by the multidisciplinary team), as well as age, and sex. Participation in the tele-reha group and the control group 1 is restricted to patients with SVS insurance. Additionally, a second control group (Control Group 2) will be recruited from patients without SVS insurance who only receive standard care. Control group 2 will be matched with the tele-reha group in terms of age group, sex and the likelihood of a positive rehabilitation outcome as estimated by the multidisciplinary team.

The study concludes with a final assessment (Final Evaluation) after 36 days of therapy. SVS patients from control group 1 will be offered the opportunity to participate in an additional tele-care intervention after the study ends. "EvoCare" is the platform for implementing the tele-care intervention, with most of the therapeutic content, such as exercise and training videos, produced by the NRZ. In addition, therapeutic content with a focus on cognition is entered into EvoCare and made available. Interventions will be selected based on the patient's primary concern in therapy, with a maximum of two activity goals and a maximum of two treatment foci set. Patients assigned to one of the control groups will continue with the standard care procedure, consisting of a paper-based home-exercise programme provided by the NRZ after discharge from the rehabilitation centre. This intervention is a programme of exercises for the basic motor skills of mobility, sensitivity, strength, endurance, balance and coordination. The supervising therapists select the content during the inpatient treatment and relate it to the patient's structural and activity-related limitations. The patients are given this paper-based programme at the end of their stay and then perform the exercises independently at home without further support.

Conditions

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Neurologic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
To minimise observer bias, the assessors will be blinded and will have no knowledge of the group allocation. The assessors will only be involved at the assessment time points, but at no other stage of this study.

Study Groups

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Intervention Group Tele-reha (1)

Tele-reha group

Group Type EXPERIMENTAL

Tele-Reha provided with EvoPads

Intervention Type DEVICE

Exercises and cognitive training provided on an EvoPad

Control Group Paper-based exercises (1)

Paper-based exercises with option to do tele-reha afterwards

Group Type ACTIVE_COMPARATOR

Paper-based exercises with option to do tele-reha afterwards

Intervention Type OTHER

Similar exercises and cognitive training as Group 1 provided on paper. Patients receive the Tele-Reha afterwards

Control Group Paper-based exercises (2)

Only paper-based exercises

Group Type ACTIVE_COMPARATOR

Only paper-based exercises

Intervention Type OTHER

Same exercises and cognitive training as Group 2 provided on paper only.

Interventions

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Tele-Reha provided with EvoPads

Exercises and cognitive training provided on an EvoPad

Intervention Type DEVICE

Paper-based exercises with option to do tele-reha afterwards

Similar exercises and cognitive training as Group 1 provided on paper. Patients receive the Tele-Reha afterwards

Intervention Type OTHER

Only paper-based exercises

Same exercises and cognitive training as Group 2 provided on paper only.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* aged 18 years or older,
* experiencing problems with motor function, sensory function, cognition, swallowing or speech production (regardless of their diagnosis),
* being insured with SVS,
* agreeing to telerehabilitation after discharge,
* having sufficient motor and cognitive abilities to operate a smartphone, tablet or PC, or being sufficiently supported by caregivers, and
* being able to independently perform the targeted tasks assigned to them.

Exclusion Criteria

\- pronounced impairments in awareness, memory, attention, spatial performance, executive performance, apraxia, speech, and visual perception that do not allow a safe study participation according to the treating physicians or therapists
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Neurologisches Rehabiliationszentrum Rosenhügel

OTHER

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Valentin Ritschl

Postdoctoral Researcher in Outcomes Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status RECRUITING

Countries

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Austria

Facility Contacts

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Tanja Stamm, PhD

Role: primary

Other Identifiers

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NRZ_Tele_Reha

Identifier Type: -

Identifier Source: org_study_id