Our study uses a two-step approach. In the first step (study part 1), we will assess the feasibility of the ADJUST-AFO to measure the optimization parameter, walking energy cost, while changing the stiffness during 20 minutes walking in healthy…
ID
Source
Brief title
Condition
- Neuromuscular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
In study 1, feasibility will be assessed as the ability to complete the
ADJUST-AFO stiffness variation protocol without the necessity to stop due to
pain, fatigue or discomfort measured on a 10-point numeric rating scale (NRS).
For study 2, the feasibility of the ADJUST-AFO in people with calf muscle
weakness will be assessed with, as primary outcomes, the ability to complete
the optimization procedure (similar to study 1) and the difference in selected
optimal stiffness for walking energy cost minimization compared to the usual
care method.
Secondary outcome
Secondary outcomes in study 1 include occurrence of possible pressure sores or
other adverse events (assessed by the researcher).
Secondary outcomes in study 2 include: occurrence of possible pressure sores or
other adverse events (assessed by the researcher) and walking energy cost with
the optimal stiffness (absolute value, in J/kg/m), walking speed (in m/s),
heart rate (b/min), perceived fatigue and gait kinematics between the usual
care method and the ADJUST-AFO method over-ground. Additionally, satisfaction
with and time needed for the usual care optimization procedure and the
ADJUST-AFO procedure will be recorded.
Background summary
In many slowly progressive neuromuscular diseases, calf muscle strength
declines over time, leading to walking problems such as instability and
increased energy cost of walking. The mainstay of treatment to improve walking
in these patients is the provision of an ankle-foot orthosis (AFO). The effect
of an AFO on walking, particularly on energy cost, depends on its stiffness. To
maximize treatment outcomes of AFOs, the stiffness needs to be individually
optimized. Currently, this optimization process consists of multiple 6-minute
walk tests with different AFOs to select the optimal stiffness, which is
time-consuming (+/- 8 hours for all tests together) and demanding for patients.
To shorten the optimization, we recently developed, within the Amsterdam UMC,
an AFO of which the stiffness can be continuously altered while walking, the
ADJUST-AFO, requiring one single walk test of 20 minutes to select to optimal
stiffness (combined called AFO-ADJUST optimization procedure).
Study objective
Our study uses a two-step approach.
In the first step (study part 1), we will assess the feasibility of the
ADJUST-AFO to measure the optimization parameter, walking energy cost, while
changing the stiffness during 20 minutes walking in healthy individuals.
In the second step (study part 2), the objective is to determine the
feasibility of the stiffness variation protocol and the concurrent validity of
the ADJUST-AFO optimization procedure to select the optimal stiffness in people
with neuromuscular diseases exhibiting calf muscle weakness, with the current
usual care procedure as comparator.
Study design
A cross-sectional design will be used to assess the feasibility of the
stiffness variation protocol (study 1).
For assessing the feasibility and concurrent validity of the ADJUST-AFO
optimization procedure, a pre-post design will be used (study 2).
Intervention
Participants will undergo an AFO-stiffness optimization procedure with the
ADJUST-AFO (in both study part 1 and part 2). The ADJUST-AFO is an orthotic
device of which the stiffness can be altered during walking by moving a slider
actuated by an on-board motor. During the procedure, participants will walk for
approximately 20-minutes with the ADJUST-AFO. Simultaneously, energy cost of
walking and gait biomechanics are recorded.
While walking overground, the AFO stiffness will be randomly changed every 3
minutes into the same five stiffness levels as applied in usual care (range 2.8
to 6.6 Nm/degree), and outcomes will be compared with the optimization
procedure as currently used in clinical practice. In usual care, the stiffness
is manually adjusted, and for each stiffness level, a 6-minute walking energy
cost test and gait analysis is performed.
Study burden and risks
Participants in study 1 will visit the hospital twice, for approximately 2
hours per visit to perform the stiffness variation protocol. During the visit,
the optimization will be performed on a treadmill, and if it is deemed safe, a
second optimization will be performed over-ground on a separate day.
Participants in study 2 will have two hospital visits of approximately 2.5 to 3
hours per visit. During these visits, the optimal stiffness with the usual care
procedure (visit 1) and with the ADJUST-AFO while walking over-ground (visit 2)
will be determined. Possible discomfort in both study 1 and 2 may include
muscle soreness, fatigue and physical discomfort due to walking with a new AFO.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
For healthy subjects:
- age >=18 years;
- no history of lower leg injuries or diseases affecting the gait pattern.
For patients:
- age >=18 years;
- presence of uni- or bilateral calf muscle weakness as determined by a manual
muscle test score <5 or unable to perform three consecutive heel-rises on 1 leg;
- estimated to be able to walk for 20 minutes with the ADJUST-AFO;
- indicated for a (new) stiffness-optimized dorsal leaf AFO.
Exclusion criteria
For healthy subjects:
- weight >120 kg;
- wearing a Cardiac Implantable Electronic Device (CIED).
- pregnancy
For patients:
- weight >120 kg;
- wearing a Cardiac Implantable Electronic Device (CIED);
- indication for a knee-ankle-foot orthosis;
- pes equines during standing, i.e. not able to achieve a neutral ankle angle
during standing;
- pregnancy
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL84470.018.23 |