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StrokeNCT05258500

Strength Training in Hospitalized Patients Using the Ghostly App: a Feasibility Study

A study testing Ghostly app, Blood flow restriction and Leaflet in people with Stroke and COVID-19, run by Vrije Universiteit Brussel at 2 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this feasibility study is to evaluate the use of the Ghostly app in rehabilitation of stroke patients, elderly and patients recovering from COVID-19 or ICU patients. In three randomized controlled trials, the effect of a strength training program incorporated in the Ghostly app will be assessed for 1)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, COVID-19, Frailty
What is being tested?
Ghostly app, Blood flow restriction and Leaflet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesBelgium
Study dates
1 Jul 2023to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Hospitalized
  • Subacute/acute stroke
  • Score of 19 or lower on the knee and hip movement test of the Motricity Index
  • Hospitalized
  • 65+ yrs
  • 14 or less repetitions on the 30 seconds sit-to-stand test
Show all 9Show fewer
  • Hospitalized
  • Recovering from COVID-19 or ICU patient
  • score of 2 or less for manual muscle testing of the quadriceps muscle in both legs

Who cannot join

  • Unable to understand the instructions
  • Other disabilities (muscular, orthopedic, …)
  • Pregnancy
  • Metal implants
  • Implanted electrical devices
  • Unable to understand the instructions
Show all 14Show fewer
  • Other disabilities (muscular, orthopedic, …)
  • Metal implants
  • Implanted electrical devices
  • Unable to understand the instructions
  • Other disabilities (muscular, orthopedic, …)
  • Pregnancy
  • Metal implants
  • Implanted electrical devices

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites
  • University Hospital Brussels

    Brussels, 1090

  • Vrije Universiteit Brussel

    Jette, Brussels Capital, 1090

Other trials in Belgium

About this study

The goal of this feasibility study is to evaluate the use of the Ghostly app in rehabilitation of stroke patients, elderly and patients recovering from COVID-19 or ICU patients. In three randomized controlled trials, the effect of a strength training program incorporated in the Ghostly app will be assessed for 1) stroke patients suffering from weakness of the lower limb, 2) frail elderly with gait difficulties and 3) patients recovering from COVID-19 or ICU patients who suffer from muscle weakness. Additionally, the effect of BFR on strength gain in all these three populations will be tested.

Read the detailed description

STUDY DESIGN: The focus of this study can be divided into two research questions. On the one hand, the effectiveness of the Ghostly app (as an additional training to conventional therapy) in relation to strength gain will be investigated. And on the other hand, the effect of BFR during isometric strength training compared to standard isometric strength training will be tested. For this study, a gaming app (Ghostly) was developed in which the main character is controlled through muscle contractions measured using electromyography (EMG). EMG-electrodes connected to the Ghostly app will be placed on the targeted muscles and register muscle contractions. The purpose of the app is to train the muscles in a stimulating and challenging environment by completing levels. These levels are adjusted to adhere to strength training guidelines based on literature. In total three single-blinded randomized controlled trials (RCT) will be organized in which one RCT investigates acute and subacute stroke patients, one RCT investigates hospitalized elderly and one RCT investigates patients recovering from COVID-19 and ICU patients. Each population will be randomized into three groups using sealed envelopes containing ten notes which will be marked with "Ghostly", followed by "A"(conventional therapy) or "B" (blood flow restriction), and five notes marked "leaflet". Every group will receive dose-matched conventional therapy, but the second experimental group will receive an adjusted version of their conventional therapy which includes isometric strength training using blood flow restriction. Each group will also receive instructions for an additional strength training program which participants will have to complete unsupervised. The first and second group will receive the strength training program incorporated in the Ghostly app. The control group on the other hand will be given a leaflet which includes instructions on performing exercises without the use of the Ghostly app. These exercises will be matched in terms of repetitions, sets and inter-set rest to match the intensity of the Ghostly app.

ANALYSIS: After the data for the entire sample is collected, the analysis will be performed using SPSS 27 (IBM, New York). A significance level of 0.05 will be used throughout the entire analysis.

Descriptive statistics of the baseline characteristics of all participants will be performed. A normal distribution of the data will be assessed using the Levene's test. Two-way repeated measures analysis of variance (ANOVA) will be used to assess the differences in dependent variables with respect to within-group variables and between-group variables. These differences will be expressed as mean differences. Additionally, a Tukey post hoc test will be done to compare mean differences for true significance.

For the analysis of the USE questionnaire, percentage distribution of every item and mean scores for every subscale will be calculated using Microsoft Excel (Microsoft, Washington, DC).

Being tested
Ghostly app, Blood flow restriction, Leaflet
Medical subject headings
Stroke, COVID-19, Frailty, Muscle Weakness, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ghostly appOther

    For the Ghostly app, we include three different trainings (standard, cluster set 1, cluster set 2). The standard training consists of three sets in which twelve muscle contractions are performed with 120 seconds of rest between each set. Each set of twelve contractions will be considered as one level in the game that needs to be ended before taking rest of 120s. Subsequently, the 'Cluster set 1' training is based on the training modalities of cluster set training since evidence shows that similar results can be obtained using cluster set training compared to standard training. The Cluster sets 1 and 2 also consist of 3 sets of twelve repetitions, but with ten seconds of rest between each contraction or 30 seconds of rest after three consecutive contractions respectively. The intensity at which will be trained is 75% of maximum voluntary contraction.

  • Blood flow restrictionOther

    Patients will complete four sets of 15 repetitions, with each contraction lasting three seconds. Similar to the first experimental group and control group, the training intensity will be set at 100%MVC with two minutes of rest between sets. The cuff pressure will be set at 50% of arterial occlusion pressure.

  • LeafletOther

    This training program will be matched with the Ghostly game in terms of repetitions, sets and inter-set rest and will be given to the patient to complete without supervision of the therapist.

Study groups in NCT05258500
Study groupRoleWhat they receive
GhostlyExperimentalThe first arm consists of a strength training program incorporated in the Ghostly game that will be given to the patient to be completed without supervision of the therapist as an added exercise program to their conventional therapy.
Receives: Other: Ghostly app
Blood flow restriction and GhosltyExperimentalThe second intervention arm incorporates blood flow restriction into the conventional therapy using the Smart Cuffs PRO system (Smart Tools, USA). Additionally, these participants will receive additional exercises added to their conventional therapy using the Ghostly game
Receives: Other: Ghostly app; Other: Blood flow restriction
ControlActive comparatorThe control group will not be given the Ghostly game as additional exercises to complete after their conventional therapy, but will receive instructions for a strength training program targeting the same muscles as both intervention groups.
Receives: Other: Leaflet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in muscle strength from baseline to 2 weeks of intervention

    Muscle strength of the quadriceps muscle will be measured using the MicroFET dynamometer

    Measured: From baseline to 2 weeks of intervention

  2. Change in muscle strength from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    Muscle strength of the quadriceps muscle will be measured using the MicroFET

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

Secondary outcomes (19)
  1. Change in cross sectional area of the muscle from baseline to 2 weeks of intervention

    Cross sectional area of the quadriceps muscle will be measured using ultrasound (Viamo sv7 device)

    Measured: From baseline to 2 weeks of intervention

  2. Change in cross sectional area of the muscle from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    Cross sectional area of the quadriceps muscle will be measured using ultrasound (Viamo sv7 device)

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  3. Change in pennation angle from baseline to 2 weeks of intervention

    Pennation angle of the quadriceps muscle will be measured using ultrasound (Viamo sv7 device)

    Measured: From baseline to 2 weeks of intervention

  4. Change in pennation angle from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    Pennation angle of the quadriceps muscle will be measured using ultrasound (Viamo sv7 device)

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  5. Change in echo intensity from baseline to 2 weeks of intervention

    Echo intensity of the quadriceps muscle will be measured using ultrasound (Viamo sv7 device)

    Measured: From baseline to 2 weeks of intervention

  6. Change in echo intensity from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    Echo intensity of the quadriceps muscle will be measured using ultrasound (Viamo sv7 device)

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  7. Change in impedance of the body (in Ω) from baseline to 2 weeks of intervention

    Body impedance will be measured using segmental bio-impedance analysis (Quadscan 4000 device)

    Measured: From baseline to 2 weeks of intervention

  8. Change in impedance of the body (in Ω) from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    Body impedance will be measured using segmental bio-impedance analysis (Quadscan 4000 device)

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  9. Length of stay

    Length of stay in both the hospital and the ward will be assessed

    Measured: After 6 weeks or when the participant is discharged from the hospital

  10. Change in time spend bedridden froim baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    The time the patient is bedridden due to muscle weakness will be assessed

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  11. Change in Motricity index from baseline to 2 weeks of intervention

    For the stroke population, the knee and hip movement test of the Motricity Index will be used as a screening tool and will be assessed after the intervention.

    Measured: From baseline to 2 weeks of intervention

  12. Change in Motricity index from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    For the stroke population, the knee and hip movement test of the Motricity Index will be used as a screening tool and will be assessed after the intervention.

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  13. Change in 30 seconds sit-to-stand test from baseline to 2 weeks of intervention

    For the elderly population, the 30 seconds sit-to-stand test will be used as a screening tool and will be assessed after the intervention.

    Measured: From baseline to 2 weeks of intervention

  14. Change in 30 seconds sit-to-stand test from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    For the elderly population, the 30 seconds sit-to-stand test will be used as a screening tool and will be assessed after the intervention.

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  15. Change in manual muscle testing from baseline to 2 weeks of intervention

    For the recovering COVID-19 patients and ICU patients, manual muscle testing will be used as a screening tool and will be eassessed after the intervention

    Measured: From baseline to 2 weeks of intervention

  16. Change in manual muscle testing from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    For the recovering COVID-19 patients and ICU patients, manual muscle testing will be used as a screening tool and will be eassessed after the intervention

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  17. Change in global perceived effect (GPE questionnaire) from baseline to 6 weeks of intervention or when the participants is discharged from the hospital

    The opinion of the patient in terms of his recovery will be assessed using the Global Perceived Effect questionnaire. This questionnaire has a minimum value of 2 and a maximum value of 14, with a lower score translating to satisfied with the rate of recovery.

    Measured: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital

  18. Therapy compliance and adherence

    Therapy adherence is defined as attendance to the instructed number of sessions and will be calculated as the number of exercise sessions completed, divided by the number of sessions prescribed. Therapy compliance refers to the prescribed intensity, frequency, and duration of the exercises. This will be calculated by dividing the training load by the prescribed training load and dividing the performed number of repetitions by the prescribed number of repetitions.

    Measured: Up to 6 weeks of intervention

  19. User experience with a modified version of the USE questionnaire

    User experience of the Ghostly game will be assessed using a translated version of the self-administered Usefulness, Satisfaction and Ease of use (USE) questionnaire. This scale ranges from 30 to 210, with a higher score translating to higher satisfaction. Additionally, open questions were added to the questionnaire to uncover possible barriers and facilitators in the use of the game.

    Measured: After 6 weeks or when the participant is discharged from the hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2022
  2. Study start1 Jul 2023
  3. Primary completion31 Aug 2024
  4. Study completion31 Aug 2024

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05258500
Sponsor's protocol ID
Ghostly
Status last verified
Mar 2026
First submitted
5 Nov 2021
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Ghostly app, Blood flow restriction and Leaflet in people with Stroke and COVID-19, run by Vrije Universiteit Brussel at 2 sites in Belgium.

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 9 inclusion and 14 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: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in muscle strength from baseline to 2 weeks of intervention (time frame: From baseline to 2 weeks of intervention). The study lists 2 primary outcomes in all. 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 13 Mar 2026.

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