Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02647242 |
| Other study ID # |
UF 9193-4 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 24, 2015 |
| Est. completion date |
August 5, 2016 |
Study information
| Verified date |
December 2021 |
| Source |
University Hospital, Montpellier |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Physical activity has demonstrated its beneficial effect on functional capabilities and
quality of life in patients with PD. However, the daily physical activity remains limited in
these patients. Rhythmic auditory cueing improves spatio-temporal gait parameters in patients
with PD. The first results of BeatHealth studies have allowed us to identify the best musical
stimulation to improve these parameters and the motivation of the patients.
The originality of this study is to propose a gait auto-rehabilitation program using
BeatHealth device with optimal auditory cueing during four weeks in ecological conditions in
PD.
Observance (utilization's time), safety (falls, pain, fatigability) and efficacy (gait
parameters, balance, quality of life) will be evaluated.
Description:
Objectives Main goal: To evaluate the observance of the use of BeatHealth device in gait
auto-rehabilitation program in patients with PD.
Secondary objectives :
1. To evaluate safety by the number of falls
2. To evaluate tolerance by the evaluation of pain and fatigue
3. To evaluate the expected improvement on gate and quality of life essentialy
4. To identify predictive factors associated with a good response to the program
5. To evaluate the technical feasibility.
Methods Design : prospective and descriptive study Population : 60 patients with PD
Inclusion criteria : PD diagnosed according the international criteria form the United
Kingdom Parkinson's Disease Society Brain Bank ; gait disorder identified by the
neurologist or the rehabilitation doktor ; to be able to work 30 minutes consecutively
and without technical support Non inclusion criteria : signs for atypical parkinsonism
Main evaluation criteria:
Percentage of time of use of the BeatHealth device compared to the prescribed schedule
(30 minutes of walk, 5 times a week during four weeks : 10 hours for the complete study)
.
Secondary evaluation criteria :
n°1 - Auto-evalation of the number of falls reported by the patient on a daily agenda
before and during the rehabilitation program.
n°2 - Auto-evalation of pain with a visual analogic scale on a daily agenda before and
during the rehabilitation program.
n°3 - (a) gait functional capabilities; (b) spatio-temporal parameters of gait; (c)
motot severity of the disease(d) balance ; (e) quality of life ; (f) psychopathological
evaluations (g) auditory-sensori-motor and timing capabilities (h) sleep.
n°4 - Numbers of correct connections to the program, number of errors of manipulations,
number of phone calls for help.
Statistical analysis : In the randomized control study on 21 patients from Martin et al.
(2015) evaluating a rehabilitation programm on rythmic auditory cueing by metronome in
patients with PD wiht fall potential, program observance was 83% according to self
evaluation by the patients. In our study , to estimate this percentage of about 80% with
an accuracy of ± 10% (interval of 20%) with a confidance interval of 95, the number of
subjects to include is 60.
Main statistical analysis : in order to evaluate the observance of the BeatHealth
device, the percentage of the time of use conpared to the prescribed time (10 hours in
total)
Program schedule :
Number of visits : 3 Inclusion period : 7 months Follow-up : 2 weeks (from the inclusion
to the beginning of the program) + 4 weeks (program) Calendar of the study : january
2016 - october 2016
Content of the visites :
V0=Inclusion / identification of the favorite musical genres of the patient /
Explanation and delivery of the agenda.
V1=
- Evalutation criteria
- Information and training to the BeatHealth device use (sensors, smartphone use,
connexion to the cloud for the transfer of the results)
- Operating instructions delivery
- Explanation of the rehabilitation program (number of sessions, duration, place…)
- Communication of the contact details of the maintenance operator V2= identical to
V1 (except for predictive factors).
Description of the intervention The auto-rehabilitation program will consist in an
outside walk, during 5 sessions of 30 minutes per week during 4 weeks with the
beatHealth device, delivering the optimal rythmic auditory cueing. The device will
associate an Android smartphone, hold at the belt, connected by bluetooth to a headphone
and to two sensors strapped to the ankles. The patient will transfer the data collected
by BeatHealth to a secured website and will complete the agenda
