Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings
Source: ClinicalTrials.gov NCT03302741 ↗No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Spasticity as Assessed by Reflex Torque of Elbow Flexors |
2.71; 1.89; 3.29; 2.85 | — |
| PRIMARY Spasticity as Assessed by Reflex Torque of Elbow Flexors |
2.71; 1.89; 3.29; 2.85 | — |
| PRIMARY Spasticity as Assessed by Reflex Torque of Elbow Flexors |
2.71; 1.89; 3.29; 2.85 | — |
| SECONDARY Spasticity as Assessed by the Modified Ashworth Scale (MAS) |
0; 0; 0; 0; 2; 2 | — |
| SECONDARY Spasticity as Assessed by the Modified Ashworth Scale (MAS) |
0; 0; 0; 0; 2; 2 | — |
| SECONDARY Spasticity as Assessed by the Modified Ashworth Scale (MAS) |
0; 0; 0; 0; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- a history of not more than one stroke which occurred at least 6 months prior to study enrollment;
- elbow flexor spasticity rated at 2 or 3 on Modified Ashworth scale (MAS);
- receiving repeated botulinum toxin injection every 3-4 months;
- absence of excessive pain in the paretic upper limb;
- capacity to provide informed consent, with Mini-Mental State Examination (MMSE) must be 25 or higher;
The following modified Ashworth scale (MAS) will be used for spasticity assessment:
0 -No increase in muscle tone; 1 -Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ -Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM; 2 -More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved; 3 -Considerable increase in muscle tone, passive movement difficult; 4 -Affected part(s) rigid in flexion or extension.
Exclusion Criteria
- recent botulinum toxin injection < 4 months;
- recent changes in antispastic medications <3 weeks (i.e., the antispastic medication regime is not stable;
- Changes in antispastic medications (such as baclofen, tizanidine, dantrolene etc) during the followup research visits. (NOTE: it is clinically rare for patients who receive repeated injections to change their antispastic medications);
- history of spinal cord injury or traumatic brain damage;
- history of serious medical illness such as cardiovascular or pulmonary complications;
- any condition that, in the judgment of a physician, would prevent the person from participating.
Data sourced from ClinicalTrials.gov (NCT03302741). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.