The objective of this study is testing the efficacy, practical utility and user-friendliness of a trunk angle sensor and feedback device (Parkinson Assist, 2M Engineering Ltd) in the home setting of patients with Parkinson's disease with a…
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
primary outcome:
1. trunk position characteristic of mean time of "good posture" and "stooped
posture" evaluated from the trunk angle data obtained during the baseline
(week 1) and the intervention (week 2)
2. VAS score of patient satisfaction, feasibility and user friendliness of the
Park Assist
Secondary outcome
1. trunk position characteristics and activity level: percentage of corrections
after feedback signal (week 2)
2. Unified Parkinson's Disease Rating Scale (UPDRS) motor section
3. 10 meter walk test
4. functional reach test
5. Timed get up and Go test
6. Occiput to wall distance
7. C7 to wall distance
8. Berg Balance Scale
9. PDQ 39
Background summary
One of the motor symptoms of Parkinson*s Disease (PD) is a characteristic
stooped posture of the trunk with drooped shoulders(1) .
While the cause is essentially unknown, this postural deficit has been linked
to postural instability and rigidity, two other key symptoms of the
disease(2;3).
Stooped posture is less susceptible to drug therapy and can impair the
patients* ability to walk and perform other daily activities, which has a major
impact on quality of life. On the other hand, the stooped posture lowers the
centre of gravity and may improve patients ability to control postural control
while standing and walking. Currently, there is the general assumption that
physical therapy should focus on improving postural strategies during daily
activities(4 5). In addition, rhythmic as well single sensory cues can be used
to facilitate gait and balance performance in PD (6-8).
One of the disadvantages of existing therapy programs is that they are mostly
applied and evaluated in an outpatient clinical setting, while the impact of
having a stooped posture (as are other motor symptoms) in patients* home
environment is unknown. Moreover, assessment in a clinically test setting may
underestimate the severity of having a stooped posture, in particular knowing
that patients are able to restore their trunk posture when conscious attention
is asked.
One way of coping with these disadvantages in patients own home setting is to
monitor and correct posture using an ambulatory device that provides online
feedback using a sensory cue when the trunk angle exceeds a threshold value.
However, the efficacy, practical utility and user-friendliness of such a method
remains to be determined.
Study objective
The objective of this study is testing the efficacy, practical utility and
user-friendliness of a trunk angle sensor and feedback device (Parkinson
Assist, 2M Engineering Ltd) in the home setting of patients with Parkinson's
disease with a stooped posture.
Ultimately, the aim is to use the device in a regular therapeutic setting.
Study design
The Parkinson Assist will be tested in a repeated measurement single subject
design. (Pilot study)
Intervention
All participants will wear the Parkinson Assist (ambulatory trunk angle sensor
and feedback device) in the home environment for two times one week, with
minimally a one week interval.
The first week consists of baseline measurements, the sensor or the Park Assist
is active and records actual trunk angle continuously in a memory chip, the
feedback signal is not active.
The second week, one week later, the patient will in addition receive online
feedback of their stooped posture by the Park Assist device (a single cue in
the form of a vibration) whenever the angle exceeds a predetermined threshold.
This threshold will be determined at the beginning of the baseline session.
Patients will be instructed on the use of the device prior to wearing it.
Study burden and risks
Burden associated with participation may be the fact that the Parkinson Assist
device is attached to the body for two seperate weeks. It is a small light
weight device comparable with a mobile phone and it is carried underneath the
clotes in a pouch at the sternum, which is with a strap around the thorax
connected to the body.
If the time that the patient is active walking and standing is more than usual
during the use of the device, the time that he is exposed to the risk of
falling is also extended and might lead to a higher number of falls, although
in comparable exercise interventions with Parkinson's disease patients, there
were no changes in number of falls when Parkinson patients were more active
during the intervention period.
The benefit for the patients may be that they experience a better control and
possibility to correct their stooped posture and are able to walk better and
take part in daily activities.
The partner of the Parkinson patient may feel less burden because the device is
giving feedback about the stooped posture and he or she does not have to
correct the patient anymore.
de Boelelaan 1117
1081 HV
NL
de Boelelaan 1117
1081 HV
NL
Listed location countries
Age
Inclusion criteria
1. patients with Parkinson's Disease with Hoehn and Yahr stage 1-3,
2. stooped posture as a major motor symptom (score 2 or higher on item 28 "posture" of the UPDRS (Unified Parkinson's Disease Rating Scale)
3. patients are able to correct their posture when attention is asked
4. sufficient cognitive function (MMSE > 24)
5. Parkinson's medication is stable during the study period
Exclusion criteria
absence of (other) neurological, cardiovascular or orthopaedic problems that can impair participation.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL31556.029.10 |