The primary objective of this study is to define and evaluate the clinimetric properties of the SMT in terms of validity and reliability.
ID
Source
Brief title
Condition
- Movement disorders (incl parkinsonism)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters in this study are derived from the surface EMG, force
and angle.
Secondary outcome
The results of the clinical scales that are used (Perceived Resistance to
Passive Movement (PRPM) an the VAS scale)
Background summary
Spasticity is a phenomenon which can occur after an upper motor neuron (UMN)
lesion. Although the cause of spasticity is not completely understood, the
current idea is that it is caused by a net loss of inhibition of spinal
reflexes. Spasticity treatment is important for an optimal rehabilitation, but
nowadays there are no objective measurement tools available yet. In clinical
settings, the Ashworth scale is still used, although studies have shown that
this measurement tool is neither sufficiently valid nor reliable. Therefore a
potentially objective measurement tool is developed at Roessingh Research &
Development. The aim of this study is to determine the clinimetric properties
of the Spasticity Measurement Tool (SMT).
Study objective
The primary objective of this study is to define and evaluate the clinimetric
properties of the SMT in terms of validity and reliability.
Study design
The study has a cross-sectional design.
Study burden and risks
The risks for the subjects are limited to a minimum, since the movement tasks
represent functional and familiar arm movements and are performed only within
the scope of the subject*s ability while he/she is seated. In addition, the
measurements used in this study (EMG, kinematics, functional scales) are all
noninvasive and involve no risks to the patients in any way. Participation of a
subject in this experiment has no direct benefit for him/her, other than
expanding knowledge about the clinimetric properties of the SMT measurement
tool.
Roessinghbleekweg 33b
7522 AH Enschede
NL
Roessinghbleekweg 33b
7522 AH Enschede
NL
Listed location countries
Age
Inclusion criteria
patients:
1. A history of a single unilateral stroke resulting in hemiparesis with spasticity in the lower arm.
2. The onset of the stroke was more than three months ago
3. The patient is above 18 years.
4. Adequate cognitive functions to understand the experiments, follow instructions, and give feedback to the researchers.
5. Ability to decide whether or not to participate in the experiment and sign an informed consent.;Healthy subjects:
1. Ability to decide whether or not to participate in the experiment and sign an informed consent.
2. Age and sex matched to the patient group.
Exclusion criteria
1. a fixed contracture deformity in the (affected) upper limb was present
2. suffering of any medical, psychological or cognitive impairment which may have compromised safety or the ability to comply with the protocol.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnummervolgt,trialgeregistreerdbijwww.trialregister.nl |
| CCMO | NL35925.044.11 |
| OMON | NL-OMON25852 |