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

NCT05940584 | Recruiting

• 1 other identifier: NRZ_Tele_Reha
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neurologic Disorder

Outcome Measures

Primary Outcomes (1)

• Assessment of change in the Functional Assessment Measure (Changes from baseline measurement to evaluation at the end of inpatient rehabilitation to evaluation after the tele-rehab intervention)

  Score 18-126 (higher score indication better functioning in everyday life)

  Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1), Evaluation after tele-reha up to 10 weeks after T1 (T2)

Secondary Outcomes (9)

• Quality of Life Measure

  Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2)

• Pain level at the moment

  Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2)

• Pain level on average in the last weeks

  Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2)

• Health Status

  Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2)

• Center for Epidemiologic Studies Depression Scale (CESD)

  Baseline evaluation at start of inpatient rehabilitation (in protocol referred to as T0), Evaluation at the end of inpatient rehabilitation up to 12 Weeks after T0 (in protocol referred to as T1) , Evaluation after tele-reha up to 10 weeks after T1 (T2)

Study Arms (3)

Intervention Group Tele-reha (1)

EXPERIMENTAL

Tele-reha group

Device: Tele-Reha provided with EvoPads

Control Group Paper-based exercises (1)

ACTIVE COMPARATOR

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

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

Control Group Paper-based exercises (2)

ACTIVE COMPARATOR

Only paper-based exercises

Other: Only paper-based exercises

Interventions

Tele-Reha provided with EvoPads DEVICE

Exercises and cognitive training provided on an EvoPad

Intervention Group Tele-reha (1)

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

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

Control Group Paper-based exercises (1)

Only paper-based exercises OTHER

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

Control Group Paper-based exercises (2)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Neurologisches Rehabiliationszentrum Rosenhügel: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Researcher in Outcomes Research

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 11, 2023
• Study Start: July 14, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 14, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)