CompletedNot Applicable

Short-term Effect of Positioning Cushions and Harmonic Techniques on Paratonia in Persons With Dementia

Belgium22 participantsStarted 2016-04-24

Plain-language summary

This study investigated the short-term effect of both harmonic techniques and supporting cushions on muscle tone, range of motion, pain and daily care activities in 22 patients with moderate to severe paratonia. The study consisted of two parts, each part was conducted during one week. In the first part of the study the short-term effect of supporting cushions was examined; in the second part of the study the additional short-term effect of harmonic techniques was investigated.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * dementia (confirmed in medical file) * presence of moderate to severe paratonia (confirmed with PAI and MAS) * proxy consent Exclusion Criteria: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in muscle tone of biceps brachii and rectus femoris

Timeframe: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)

Change in maximal extension of elbow and knee

Timeframe: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)

Change in pain

Timeframe: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)

Comparison of pain during morning care

Timeframe: rated after morning care, daily during 2 weeks for each participant (control week and intervention week)

Comparison of comfort during morning care

Timeframe: rated after morning care, daily during 2 weeks for each participant (control week and intervention week)

Trial details

NCT IDNCT03538405

SponsorUniversity Ghent

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-21

View on ClinicalTrials.gov More Dementia trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * dementia (confirmed in medical file) * presence of moderate to severe paratonia (confirmed with PAI and MAS) * proxy consent Exclusion Criteria: \-

What they're measuring

Change in muscle tone of biceps brachii and rectus femoris

Timeframe: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)

Change in maximal extension of elbow and knee

Timeframe: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)

Change in pain

Timeframe: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)

Comparison of pain during morning care

Timeframe: rated after morning care, daily during 2 weeks for each participant (control week and intervention week)

Comparison of comfort during morning care

Timeframe: rated after morning care, daily during 2 weeks for each participant (control week and intervention week)