Trial · NCT02212119
Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness
NCT02212119, Phase 2, Completed, Assistive Technology Clinic, Canada
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness. Trials, record NCT02212119. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02212119
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Effectiveness of Botulinum Toxin in Elderly Patients With Dementia and Muscle Stiffness
- NCT number
- NCT02212119
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Assistive Technology Clinic, Canada
- Conditions
- Dementia, Paratonia
- Interventions
- Botulinum Toxin, Saline
- First posted
- 2014-08-08
- Last updated
- 2014-08-08
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Impact on care-giver burden | 6 weeks for primary outcome, 32 weeks for entire study | Impact on caregiver burden in providing upper extremity care. Measured by the Carer Burden Scale which includes four items (cleaning the palm, cutting the fingernails, dressing, cleaning under the armpit). Each item rated on five point Likert scale ("no difficulty" to "cannot do task"). |
| Secondary | Visual Analogue Scale | 6 weeks for secondary outcome, 32 weeks for entire study | Completed by the professional caregiver that is caring for the patient to assess perception of ease of caregiving. Consists of 100 mm line with anchors of 0 "giving care to the residents is very difficult" and 100 "giving care to the residents is very easy" |
| Secondary | Joint angle measurement | 6 weeks for secondary outcome, 32 weeks for entire study | Joint angle measurements were used reflecting range of motion. Used as a surrogate measure for severity of paratonia |
| Secondary | Pain | 6 weeks for secondary outcome, 32 weeks for entire study | Pain Assessment in Advanced Dementia (PAINAD) Scale used to evaluate correlates of pain and determine whether Botulinum toxin treatment reduces discomfort of morning care. Consists of 5 items (breathing, negative vocalization, facial expression, body language and consolability), scored on a 0-2 point scale and then summed to arrive at a total scale. |
| Secondary | Global Assessment | 6 weeks for secondary outcome, 32 weeks for entire study | Overall response to treatment evaluated by study investigator and by professional caregiver caring for patient using the global assessment scale. A score of -4 indicates very marked worsening, 0 no change, and +4 very marked improvement. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers19
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02212119
GET https://conductscience.org/api/trials/v1/NCT02212119/registered