Clinical Efficacy of a teLerehabilItation Protocol, for the Improvement of Balance in Degenerative neurOlogical Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Berg Balance Scale
研究概览
简要总结
The goal of this one blind-randomized controlled clinical trial is to evaluate the clinical effectiveness of a telerehabilitation (TR) protocol focusing on balance rehabilitation in patients with neurodegenerative diseases (Parkinson's Disease, Multiple Sclerosis).
The secondary objectives of the study are:
- To evaluate the effects of clinical treatment on Health-Related Quality of Life (HRQOL) outcomes.
- To collect data on process measures: user needs (patients and caregivers), treatment adherence, usability, satisfaction, technological acceptance.
Participants will perform 20 rehabilitation session (physiotherapy) for balance improvement. Experimental group patients will be trheated through tele-rehabilitation performing exercise with an hospital physiotherapist.
Researchers will compare telerehabilitation group to usual care group to see if there is a significant improvement in motor function, particularly in balance and mobility tests, as well as an improvement in quality of life.
详细描述
Single-blind randomised controlled clinical trial. A sample of 36 consecutive patients (18 per group) suffering from Multiple Sclerosis (N=18, 9 per group) and Parkinson's Disease (N=18, 9 per group), admitted to the San Camillo IRCCS Hospital in Venice in ordinary inpatient or outpatient care, who still need home rehabilitation, will be enrolled. patients will be randomised to receive either TR or usual care, based on an allocation generated by the website: "Sealed Envelope.com". After discharge and before treatment (T1), a researcher will conduct blinded clinical assessments, repeated after 20 rehabilitation sessions (T2), and 2 months after the end of treatment (T3). The rehabilitation modality provided by the IRCCS in telerehabilitation is based on virtual reality modalities. In particular, the experimental treatment under study involves the use of the VRRS-TR system (Khymeia Group s.r.l, Noventa Padovana), which consists of
- n.1 Tablet complete with keyboard, power supply, telerehabilitation application (Virtual Reality Rehabilitation System- VRRS);
- no.1 multi-USB device with cable for USB-mini port
- n.1 video camera;
- no.1 wide-angle lens and its attachment;
- no.1 K-wand;
- no.2 KHIMU wireless inertial sensors with power supply
- 1 USB dongle for communication with KHIMU sensors
- n.7 Velcro strips These technologies will be delivered to the patient and will be used at home, through a two-way on-line connection by means of Synchronous Telerehabilitation, with an IRCCS physiotherapist, who will deliver the treatments through a dedicated workstation (Telecokpit), with which it will be possible to manage the patient's tablet through the "Teamviewer" app, interacting with the latter and monitoring the execution of the exercises through the videoconference implemented in the system.
The virtual environment makes it possible to administer a high dose of repetitions of the movement of interest; for each exercise, the quality of execution is monitored in real time, i.e. through the return of feedback to the subject through visual, acoustic and vocal indications. Finally, various parameters, such as the distance of the targets to be reached, the sensitivity, the number of repetitions and the dwell time on the different targets, allow the difficulty of the exercise to be increased or decreased. In order to perform the rehabilitation protocol in telerehabilitation, inertial sensors (KhyMU) are used, which are applied to the part of the body that will become the effector of the movement. The sensors are applied using special elastic bands on the front part of the trunk and the front part of the thighs/legs/arms. Depending on the movement to be trained, the therapist decides whether to use one sensor or both.The exercises proposed to the control group will be performed by the latter at home, in self-treatment. Type, intensity, duration and objectives of these exercises are structured to be as similar and homogeneous as possible to those performed by means of the VRRS system in Telerehabilitation. In order to carry out the therapies, the patient will be given a booklet with a precise description of the exercises to be performed accompanied by explanatory pictures. This file is created through the website: www.physiotherapyexercises.com. On a weekly basis, a physiotherapist will contact the patient by telephone to inquire about the progress of the therapies, giving indications on how to modify the modalities, number of repetitions, duration and difficulty of the exercises, maintaining the logic of incremental training adopted in the TR group protocol. The patient will also be provided with a monitoring diary of the activities performed, corresponding to the automatic reporting system implemented in the VRRS system, used instead for the TR group.
Follow-up (T3) At the end of the treatment protocol, two months after the final evaluation (T2), a Follow-Up will be carried out by means of a brief telephone survey to monitor the state of health, autonomy in ADLs, number of falls and perception of safety with respect to one's own balance of the patients enrolled in this project.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Possession of an ADSL internet connection with a flat rate or, in the case of a pay-as-you-go tariff, with an availability of at least 20 Gigabytes/month.
- •PARKINSON'S DISEASE:
- •Patients with Parkinson's disease, according to the criteria of the UK Parkinson's Disease Society Brain Bank, in stabilised pharmacological treatment with L-Dopa or dopamine agonists and with a Hoehn & Yahr scale score between 1.5 and 2.5;
- •Patients presenting a score ≤ 2 in the 'freezing when walking' subitem of section II of the UPDRS;
- •Patients presenting a score ≤ 2 in both duration and disability in the "dyskinesias" sub-item of section IV of the UPDRS.
- •MULTIPLE SCLEROSIS
- •Subjects with Multiple Sclerosis (MS) in the relapsing remitting (RRMS) or secondary progressive (SPMS) forms, according to the criteria of MC Donald 2010 [14], under stable drug treatment and with Expanded Disability Status Scale (EDSS) score ≤ 6.5;
- •At the time of inclusion, at least 3 months have elapsed since the last relapse.
排除标准
- •All patients will be excluded from the study who, in association with the diagnosis of the diseases listed above, have the following comorbidities diagnosed and documented in the medical records
- •Unstabilised fractures;
- •Diagnosis of major depression;
- •Severe deficits in visual acuity and hearing perception;
- •Dementia;
- •Epilepsy not controlled pharmacologically;
- •Ideomotor apraxia;
- •Severe impairment of verbal comprehension
结局指标
主要结局
Berg Balance Scale
时间窗: Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.
The Berg Balance Scale (BBS) objectively assesses a patient's ability to safely maintain balance during 14 predetermined tasks. Each item is scored on a 5-point ordinal scale (0-4), with 0 indicating the lowest level of function and 4 the highest. The assessment takes approximately 20 minutes and excludes gait evaluation. Possible scores range from 0 to 56, with higher scores indicating better balance function.
次要结局
- Ten metres walking test (10MWT)(Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.)
- Short-Form-36 health outcome (SF-36)(Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.)
- Mini-Balance Evaluation System Test (Mini-BESTest)(Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.)
- Functional Ambulation Classification (FAC)(Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.)
- 5X Sit-to-Stand Test (5XSST)(Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.)
- Activities specific-Balance Confidence (ABC) -Scale(Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.)
- Barthel Index (BI)(Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline.)
- Six Minutes Walking Test (6MWT)(Change from Baseline (T1) to Post-intervention (T2), approximately 6 weeks after baseline)
- Falls questionnaire (last year-last 2 months)(Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.)
- EuroQol-5 Dimensions, 3 Levels (EQ-5D-3L)(Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.)
- Instrumental Activities of Daily Living (IADL)(Change from Baseline (T1) to Follow-up (T3), approximately 12 weeks after baseline.)
- Client Satisfaction Measure Questionnaire (SMQ)(At Post-intervention (T2), approximately 6 weeks after baseline.)
- System Usability Scale (SUS)(At Post-intervention (T2), approximately 6 weeks after baseline.)
- Technology acceptance questionnaire (TAM)(At Post-intervention (T2), approximately 6 weeks after baseline.)
研究者
Sara Federico
Dr
IRCCS San Camillo, Venezia, Italy