Geriatric Diseases Clinical Trial
Official title:
The "Feedback Integrated Rehabilitation for Sit-to-stand Training": a Pilot Randomised Controlled Trial Testing Clinical Acceptability and Effectiveness
The sit-to-stand (STS) movement is a key functional movement critical to independent living.
This movement is physically demanding to conduct, especially in older adults, and in the
presence of physical impairments associated with a range of conditions, such as stroke,
osteoarthritis, Parkinson disease and hip arthroplasty. A limited capacity to perform this
movement increases the risk of falls, dependency and increased support for personal care and
rehabilitation. Restoring independence in this movement is, therefore, considered a priority
for physical rehabilitation.
Sit-to-stand capacity can be regained through participating in rehabilitation exercises.
Providing feedback on performance of this movement could enhance the training. Thus, it is
an essential aspect of physical therapy. Healthcare providers are required to meet the needs
of an increasingly frail population as well as meeting national, evidence-based, guidelines
for improving outcomes in conditions such as stroke which includes an increase in the
practice repetition of functional movements. Reliance on rehabilitation staff to provide
practice, however, places a limit on practice volume, potentially restricting outcomes.
Using technology to enhance safe, repetitive practice of this movement with minimal
supervision from skilled professionals would be beneficial to patients and rehabilitation
services.
The primary aim of this study is to test the acceptability and feasibility of a STS training
system that enhances movement feedback to patients undergoing rehabilitation. A secondary
aim is to gather data on the effectiveness of the system compared to conventional
rehabilitation. This information will inform a statistically powered phase 2 trial.
Research Design:
This is a pilot randomised controlled study to test the acceptability and feasibility of a
sit-to-stand (STS) training system and gather preliminary data on its effectiveness.
Participants will be randomly allocated to an experimental group where participants will
receive sit to stand training enhanced by the feedback system or a control group where
participants will receive the usual sit to stand training as provided by the treating
therapist.
Participants and recruitment:
Patients with physical impairments that affect their capacity to perform the STS movement
and who are about to start active rehabilitation will be identified by the clinical team on
the ward. If individuals identified in this way indicate to the clinical team that they are
willing to talk to the researcher about the study a mutually convenient time will be
arranged for the researcher to speak individually to the patient about the study. An
information sheet will be left with the patient and they will be encouraged to read this and
speak to family and friends about their possible participation. No less than 48 hours after
the information sheet is provided, the researcher will make contact with the patient to
discuss their participation and take written consent if agreed. This recruitment process and
their participation in the study will not interfere with discharge planning during the
study.
Group allocation:
Sealed opaque envelopes contained randomly generated codes for treatment allocations will be
given to a member of the clinical team. Once informed consent has been provided, the
envelope will be opened randomising participants into two groups: 1) A control group who
will conduct conventional sit-to-stand training and 2) An experimental group who will
conduct augmented STS training using the feedback system. Twenty participants will be
randomly allocated to each group. Participants allocated to either group will be attached
with a physical activity monitor (ActivePAL sensor,PAL Technologies Ltd, Glasgow) by the
researcher onto the unaffected or dominant side of the thigh. Full instructions will be
provided on its use. The monitor is small and lightweight (<15 grams) but capable of
detecting and storing information on movement and position (e.g. duration of sitting,
standing and the number of STS execution 24 hours aday for 28 days).Data to record from
medical notes: Participants' background information (i.e. gender, age, height, weight,
reasons for admission and number and type of co-morbidities) will be noted.Pre-assessments:
Participants in both groups will be asked to carry out the following baseline measurements
by the researcher: 1)Timed performance of up to five repetitions of the sit to stand
movement (FTSTST), if able; 2) Abbreviated Mental Test -4 with a inclusion score of 4 or
higher (AMT-4); 3) Tinetti Gait and Balance Assessment (TGBA); 4) Elderly Mobility Scale
Test (EMST). These assessments are already being used by the clinical team. Training with
the system:The rehabilitation staff will supervise all training sessions as per normal
practice. The researcher will provide technical support for all the sessions. The
participant will be asked to sit on an adjustable chair with armrests. The height of the
chair to be adjusted by the researcher for individual needs. A loose vest with a pouch
pocket fitted near the chest region will be worn by the participant. Help will be provided
by the researcher if needed. An inertial sensor (Spatial 3/3/3, Phidgets Inc, Calgary,
Alberta, Canada) will be placed into the pocket and connected by a USB (Universal Serial
Bus) cable to a laptop computer. The participant will then be asked to place both feet on a
portable balance plate (BP5046, Bertec Inc, Columbus, OH, USA), which is also attached to
the laptop via the USB. The system provides a virtual reality environment that simulates
user getting on and off a bus seat. The participant can observe their real-time movement as
an avatar on a computerised image (projected on a wall by a projector). Real-time feedback
on performance (balance, strength and/or coordination), verbally and visually, will be
provided throughout training. The game can be personalised to suit different needs based on
the participant's real-time performance. Training should be two to three times a week based
on advice on current practice. During the study, the researcher will check with the ward
staff that the activity monitor (ActivePAL) is still attached to the participant's thigh and
that they are free of skin irritation. The researcher will also change the monitor after
seven days so that the skin can be fully inspected and cleaned if necessary. After the
study, the monitor will be completely removed by the researcher. The captured anonymised
physical activity data will be downloaded to an encrypted folder on a computer and used
exclusively for this study. It will then be transferred to a secured computer at the
University of Strathclyde for safe storage. Post-assessment: The researcher will carry out a
repeat of the baseline measurements at the end of the study.
In addition, the following information will be recorded by the researcher on acceptability
and feasibility: 1) Number of sessions attended as a proportion of a total number of the
session available; 2)Adverse incidents, type and number; 3) acceptability of the system by a
semi-structured interview with the clinical team and participants. The anonymised data will
be analysed to address three questions:
1. Is the system feasible to use with older people undergoing inpatient rehabilitation?
2. Is the system feasible to use in a clinical environment?
3. Can the system improve sit-to-stand performance compared to conventional training?
4. Is the system acceptable from the point of view of users (patients and rehabilitation
staff)?
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