This study tests the ability of the Cue-shoe, a new cueing device, to provide patients with FoG with successful cueing.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The statistical design will focus on the comparison between the two periods of
Phase 2 (with and without visual cueing) on activity level.
Secondary outcome
• During Phase 1, the immediate effect of the Cue-shoe on gait parameters and
FoG will be investigated by comparing the trials with and without cueing.
• Application of a previously validated algorithm to detect FoG episodes and
comparison of the two periods of Phase 2 (with and without visual cueing) on
these data will give an idea of the functional efficacy of the Cue-shoe on FoG
in the home environment.
• The presence of a learning effect will be investigated by comparing the
activity level and FoG during Phase 3 with those same measures during Phase 2.
• For each of the home-based measurement, evolution of the activity level over
days will be examined with the help of the patients' diaries.
• Subjective impression of the patients on the Cue-shoe will be compared
between each time point.
• The Frontal Assessment Battery score will be used as a covariate in all
performed analyses.
Background summary
Freezing of gait (FoG) is defined as a brief, episodic absence or marked
reduction of forward progression of the feet despite the intention to walk
(Nutt et al., 2011). This symptom is one of the most debilitating of
Parkinson's disease and related diagnoses as it increases the risk of falls,
related injuries and fear of falling, impeding patients' autonomy and quality
of life (Rahman et al., 2008, Grimbergen et al., 2013). While the therapeutic
treatment of FoG remains a challenge, its characteristic to highly depend on
attentional, motivational, emotional and arousal processes opens the way for
rehabilitation strategies to provide the patients with tricks to help them
prevent and overcome their freezing episodes. External cueing is one of those
strategies (Nieuwboer, 2008). Lines placed at regular intervals on the floor,
stair tiles or the sound of a metronome are some illustrations of external
cueing and strikingly show how only one single step often separates freezing
from freedom.
Study objective
This study tests the ability of the Cue-shoe, a new cueing device, to provide
patients with FoG with successful cueing.
Study design
This study will be divided into three phases, each of those phase answering a
specific question regarding the Cue-shoe:
* Phase 1: Lab measurement: Is there an immediate effect of the Cue-shoe?
To answer this question, a lab-measurement will be conducted both Off and On
medication, preferably on two consecutive mornings.
* Phase 2: Home-based measurements: Is the Cue-shoe functionally efficient?
To answer this question, patients will be measured at home over two one week
periods, with and without visual cueing (both periods using the Cue-shoe but
with visual cueing being disabled during the period without visual cueing).
* Phase 3: Home-based measurement: Is there a learning effect from cueing
training using the Cue-shoe?
To answer this question, patients will be measured at home over one week
period, after withdrawal of the Cue-shoe
The following dependant variables will be collected:
Phase 1: Lab-measurement
- MDS-UPDRS Part III (motor part)
- Frequency and duration of FoG episodes occurring during a walking protocol
(using the DynaPort and Axivity devices)
- A composite score on specific items of the Gait and Balance Scale (Thomas et
al., 2004)
- Patients subjective impression of the Cue-shoe on a 7 points Likert scale
- Gait parameters (velocity, step length, cadence, duration of single and
double support phases)
- Score on the Frontal Assessment Battery (Dubois et al., 2000)
- Score on the Parkinson's Disease Questionnaire 39 (PDQ39)
- Score on the NFOGQ (Nieuwboer et al., 2009)
- Patients interest (yes - no - maybe) in acquiring the Cue-shoe
Phases 2 and 3: Home-based measurement
- Activity level (using the DynaPort and Axivity devices)
- Frequency and duration of FoG episodes occurring (using a previously
validated algorithm, (Delval et al., 2010))
- Score on the NFOGQ (Nieuwboer et al., 2009)
- Score on the Parkinson's Disease Questionnaire 39 (PDQ39)
- Patients subjective impression of the Cue-shoe on a 7 points Likert scale
- Subjective impression about effect on FoG episodes and falls using a
structured diary
- Patients interest (yes - no - maybe) in acquiring the cue-shoe
Intervention
Use of the Cue-shoe to improve freezing of gait.
Study burden and risks
Patients with FoG are subjects to falls. During the lab-measurement, a person
will be permanently walking next to the patients to avoid falls. We do not
expect the Cue-shoe to aggravate the risk of falls. In the unlikely case that
the lab-measurement reveals worsening of gait and FoG in some patients, those
patients will not be included in Phases 2 and 3. This study is therefore not
dangerous and poses no risk to the patients. Note however that some discomfort
is expected from resurgence of the parkinsonian symptoms following withdrawal
of antiparkinsonian medication in Phase 1.
We expect patients to physically benefit from the week with visual cueing.
Expected decrease of FoG episodes should increase their quality of life.
Likewise, they might show a learning effect from training with the Cue-shoe
during Phase 2, leading to extension of the benefit during Phase 3 or even
further.
Radboud University Nijmegen Medical Center Department of Neurology (HP 935)
Nijmegen 6500 HB
NL
Radboud University Nijmegen Medical Center Department of Neurology (HP 935)
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
• Men/women of age > 18 years.
• Written informed consent.
• Presence of freezing of gait (defined as a score of 1 on question 1 "Have you experienced FoG in the past month" from the New Freezing of Gait Questionnaire)
• Disabling freezing of gait (defined as a score of 3 "Very often, more than one time a day" on question 2 "How often do you experience FoG" from the New Freezing of Gait Questionnaire)
Exclusion criteria
• stroke in history or a psychiatric
disease
• Any visual impairment or physical inability to perform the assessment
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 | NL48032.091.14 |