Strength Training in Hospitalized Patients Using the Ghostly App: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in muscle strength from baseline to 2 weeks of intervention
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stroke population:
- •Hospitalized
- •Subacute/acute stroke
- •Score of 19 or lower on the knee and hip movement test of the Motricity Index
排除标准
- •Stroke population:
- •Unable to understand the instructions
- •Other disabilities (muscular, orthopedic, …)
- •Pregnancy
- •Metal implants
- •Implanted electrical devices
- •Inclusion Criteria Elderly:
- •Hospitalized
- •14 or less repetitions on the 30 seconds sit-to-stand test
- •Exclusion Criteria Elderly:
- •Unable to understand the instructions
- •Other disabilities (muscular, orthopedic, …)
- •Metal implants
- •Implanted electrical devices
- •Inclusion Criteria COVID-19/ICU:
- •Hospitalized
- •Recovering from COVID-19 or ICU patient
- •score of 2 or less for manual muscle testing of the quadriceps muscle in both legs
- •Exclusion Criteria COVID-19/ICU:
- •Unable to understand the instructions
- •Other disabilities (muscular, orthopedic, …)
- •Pregnancy
- •Metal implants
- •Implanted electrical devices
研究组 & 干预措施
Blood flow restriction and Ghoslty
The 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
干预措施: Ghostly app (Other)
Blood flow restriction and Ghoslty
The 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
干预措施: Blood flow restriction (Other)
Control
The 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.
干预措施: Leaflet (Other)
Ghostly
The 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.
干预措施: Ghostly app (Other)
结局指标
主要结局
Change in muscle strength from baseline to 2 weeks of intervention
时间窗: From baseline to 2 weeks of intervention
Muscle strength of the quadriceps muscle will be measured using the MicroFET dynamometer
Change in muscle strength from baseline to 6 weeks of intervention or when the participants is discharged from the hospital
时间窗: From baseline to 6 weeks of intervention or when the participant is discharged from the hospital
Muscle strength of the quadriceps muscle will be measured using the MicroFET
次要结局
- Change in pennation angle from baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Change in pennation angle from baseline to 2 weeks of intervention(From baseline to 2 weeks of intervention)
- Length of stay(After 6 weeks or when the participant is discharged from the hospital)
- User experience with a modified version of the USE questionnaire(After 6 weeks or when the participant is discharged from the hospital)
- Change in cross sectional area of the muscle from baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Change in echo intensity from baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Change in time spend bedridden froim baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Change in cross sectional area of the muscle from baseline to 2 weeks of intervention(From baseline to 2 weeks of intervention)
- Change in echo intensity from baseline to 2 weeks of intervention(From baseline to 2 weeks of intervention)
- Change in impedance of the body (in Ω) from baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Change in Motricity index from baseline to 2 weeks of intervention(From baseline to 2 weeks of intervention)
- Change in manual muscle testing from baseline to 2 weeks of intervention(From baseline to 2 weeks of intervention)
- Change in manual muscle testing from baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Change in impedance of the body (in Ω) from baseline to 2 weeks of intervention(From baseline to 2 weeks of intervention)
- Change in Motricity index from baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Change in 30 seconds sit-to-stand test from baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Change in global perceived effect (GPE questionnaire) from baseline to 6 weeks of intervention or when the participants is discharged from the hospital(From baseline to 6 weeks of intervention or when the participant is discharged from the hospital)
- Therapy compliance and adherence(Up to 6 weeks of intervention)
- Change in 30 seconds sit-to-stand test from baseline to 2 weeks of intervention(From baseline to 2 weeks of intervention)
研究者
Ruben Debeuf
The Principal Investigator
Vrije Universiteit Brussel