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van CCT (UK)

van CCT (UK)

Clinimetric properties of the SMT.

- candidate number9273
- NTR NumberNTR2823
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-mrt-2011
- Secondary IDsNL35925.044.11 METC Twente
- Public TitleClinimetric properties of the SMT.
- Scientific TitleClinimetric properties of the Spasticity Measurement Tool, an objective measurement instrument to define spasticity in stroke patients.
- hypothesisN/A
- Healt Condition(s) or Problem(s) studiedStroke, Spasticity
- Inclusion criteriaInclusion criteria for stroke patients are:
1. A history of a single unilateral stroke resulting in hemiparesis with a slight to moderate 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.

Inclusion criteria for healthy subjects are:
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 criteriaExclusion criteria for both stroke patients and healthy subjects are:
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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 15-apr-2011
- planned closingdate1-sep-2011
- Target number of participants32
- InterventionsN/A
- Primary outcomeRMS of the EMG, Force and angular velocity.
- Secondary outcome1. PRPM: An ordinal scale derived from the Asworth scale;
2. VAS scale.
- TimepointsHealthy subjects will be measured once, patients with spasticity after a stroke will be measured twice (with one week between the measurements).
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator Roessingh Research and Development
- Funding
(Source(s) of Monetary or Material Support)
Roessingh Research & Development
- PublicationsN/A
- Brief summaryRationale:
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).

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 population:
16 stroke patients with chronic spasticity and 16 healthy subjects who are age and sex matched with the patient group.

Main study parameters/endpoints:
The main study parameters in this study are derived from the surface EMG, force and angle.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
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 subjectís ability while he/she is seated. In addition, the measurements used in this study (EMG, kinematics, functional scales) are all non-invasive 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.
- Main changes (audit trail)
- RECORD25-mrt-2011 - 9-mrt-2012

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