Neurologic DisorderNCT05940584
Tele-reha Versus Paper-based Aftercare Programme Following Inpatient Rehabilitation
A study testing Tele-Reha provided with EvoPads, Paper-based exercises with option to do tele-reha afterwards and Only paper-based exercises in people with Neurologic Disorder, run by Medical University of Vienna at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Neurologic Disorder
- What is being tested?
- Tele-Reha provided with EvoPads, Paper-based exercises with option to do tele-reha afterwards and Only paper-based exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 1 siteAustria
- Study dates
- 14 Jul 2023to 14 Jan 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, State of Vienna, 1090
Tanja Stamm, PhD, +43 1 40400 ext. 16370, tanja.stamm@meduniwien.ac.at
About this study
Official title: Implementation and Evaluation of a Tele-reha As Well As a Paper-based Aftercare Programme Following Inpatient Rehabilitation: a Three-armed, Observer-blinded, Randomised Controlled Trial
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.
Read the detailed description
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
- Neurologic Disorder
- Being tested
- Tele-Reha provided with EvoPads, Paper-based exercises with option to do tele-reha afterwards, Only paper-based exercises
- Medical subject headings
- Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Reha provided with EvoPadsDevice
Exercises and cognitive training provided on an EvoPad
Paper-based exercises with option to do tele-reha afterwardsOther
Similar exercises and cognitive training as Group 1 provided on paper. Patients receive the Tele-Reha afterwards
Only paper-based exercisesOther
Same exercises and cognitive training as Group 2 provided on paper only.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group Tele-reha (1) | Experimental | Tele-reha group Receives: Device: Tele-Reha provided with EvoPads |
| Control Group Paper-based exercises (1) | Active comparator | Paper-based exercises with option to do tele-reha afterwards Receives: Other: Paper-based exercises with option to do tele-reha afterwards |
| Control Group Paper-based exercises (2) | Active comparator | Only paper-based exercises Receives: Other: Only paper-based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Numeric Rating Scale (NRS) 0-100 (higher score indicating better quality of life)
Measured: 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
NRS 0-100 (higher score indicating more symptomatology)
Measured: 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
NRS 0-100 (higher score indicating more symptomatology)
Measured: 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
NRS 0-100 (higher score indicating better health status)
Measured: 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)
0-60 (higher socre indicating more symptomatology)
Measured: 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)
ZUF 8 Patient satisfaction
1-4 (score varies according to questions)
Measured: 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)
Goal achievement scale
1-5 (higher score indicating worse goal achievement)
Measured: 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)
Experience with tele-care
1-4 (score varies according to questions)
Measured: Evaluation after tele-reha up to 10 weeks after T1 (in protocol referred to asT2)
Experience with standard care
1-4 (score varies according to questions)
Measured: Evaluation after tele-reha up to 10 weeks after T1 (in protocol referred to as T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start14 Jul 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion14 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 285 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Neurologisches Rehabiliationszentrum Rosenhügel
- Responsible party
- Principal investigator, Valentin Ritschl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05940584
- Sponsor's protocol ID
- NRZ_Tele_Reha
- Status last verified
- Dec 2024
- First submitted
- 16 Jun 2023
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation and Evaluation of a Tele-reha As Well As a Paper-based Aftercare Programme Following Inpatient Rehabilitation: a Three-armed, Observer-blinded, Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05940584
- Acronym / sponsor ID
- NRZ_Tele_Reha
- Conditions
- Neurologic Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 285 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- Neurologisches Rehabiliationszentrum Rosenhügel
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 14 Jan 2025 (estimated)
- First posted
- 11 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group Tele-reha (1) | Experimental | Device: Tele-Reha provided with EvoPadsTele-reha group |
| Control Group Paper-based exercises (1) | Active comparator | Other: Paper-based exercises with option to do tele-reha afterwardsPaper-based exercises with option to do tele-reha afterwards |
| Control Group Paper-based exercises (2) | Active comparator | Other: Only paper-based exercisesOnly paper-based exercises |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-Reha provided with EvoPadsExercises and cognitive training provided on an EvoPad | Device | Intervention Group Tele-reha (1) |
| Paper-based exercises with option to do tele-reha afterwardsSimilar exercises and cognitive training as Group 1 provided on paper. Patients receive the Tele-Reha afterwards | Other | Control Group Paper-based exercises (1) |
| Only paper-based exercisesSame exercises and cognitive training as Group 2 provided on paper only. | Other | Control Group Paper-based exercises (2) |
Primary outcome
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)
Time frame: 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)
Score 18-126 (higher score indication better functioning in everyday life)
9 secondary outcomes
Quality of Life Measure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
ZUF 8 Patient satisfaction
Time frame: 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)
Goal achievement scale
Time frame: 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)
Experience with tele-care
Time frame: Evaluation after tele-reha up to 10 weeks after T1 (in protocol referred to asT2)
Experience with standard care
Time frame: Evaluation after tele-reha up to 10 weeks after T1 (in protocol referred to as T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Reha provided with EvoPads, Paper-based exercises with option to do tele-reha afterwards and Only paper-based exercises in people with Neurologic Disorder, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.