DementiaNCT03538405
Short-term Effect of Positioning Cushions and Harmonic Techniques on Paratonia in Persons With Dementia
A study testing Supporting cushions and Harmonic techniques in people with Dementia and Paratonia, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Supporting cushions and Harmonic techniques
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Apr 2016to 21 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dementia (confirmed in medical file)
- presence of moderate to severe paratonia (confirmed with PAI and MAS)
- proxy consent
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Supporting cushions, Harmonic techniques
- Keywords
- harmonic techniques, supporting cushions, intervention
- Medical subject headings
- Dementia, Muscle Rigidity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supporting cushionsOther
Cushions were placed in a way that the head and four limbs were well supported, without leaving empty space between body and cushions or mattress.
Harmonic techniquesOther
Harmonic techniques (HT) is a group of manual techniques described by Lederman (2000).The goal of this techniques in this study was to reduce the muscle tone and additionally/subsequently increase the ROM.
| Study group | Role | What they receive |
|---|---|---|
| all participants | Experimental | All participants received the same interventions, there were no subgroups interventions: supporting cushions and harmonic techniques Receives: Other: Supporting cushions; Other: Harmonic techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle tone of biceps brachii and rectus femoris
Change in MyotonPRO measurement of intrinsic muscle tone of left and right biceps brachii and left and right rectus femoris
Measured: 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
Change in goniometric measurement of maximal elbow and knee extension
Measured: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)
Change in pain
Change in PACSLAC-D score (PACSLAC-D is a Dutch adaptation of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate): observation scale of pain during morning care. Scores range from 0 to 24, indicating the presence of various pain expressions. Higher scores indicate more pain.
Measured: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)
Comparison of pain during morning care
Comparison of PACSLAC-D scores during control week and harmonics week.PACSLAC-D is a Dutch adaptation of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate: observation scale of pain during morning care. Scores range from 0 to 24, indicating the presence of various pain expressions. Higher scores indicate more pain.
Measured: rated after morning care, daily during 2 weeks for each participant (control week and intervention week)
Comparison of comfort during morning care
Comparison of score on comfort questionnaire 4 questions regarding comfort of morning care (both for caregiver as estimated for patient) between control week and harmonics week, as rated with a visual analogue scale (0-10, interpretation dependent on the question)
Measured: rated after morning care, daily during 2 weeks for each participant (control week and intervention week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start24 Apr 2016
- Primary completion21 Dec 2017
- Study completion21 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538405
- Sponsor's protocol ID
- EC/2016/0019
- Status last verified
- May 2023
- First submitted
- 17 Apr 2018
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effect of Positioning Cushions and Harmonic Techniques on Paratonia in Persons With Dementia
- ClinicalTrials.gov ID
- NCT03538405
- Acronym / sponsor ID
- EC/2016/0019
- Keywords
- harmonic techniques, supporting cushions, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 24 Apr 2016 (actual)
- Primary completion
- 21 Dec 2017 (actual)
- Study completion
- 21 Dec 2017 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all participants | Experimental | Other: Supporting cushions, Other: Harmonic techniquesAll participants received the same interventions, there were no subgroups interventions: supporting cushions and harmonic techniques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- dementia (confirmed in medical file)
- presence of moderate to severe paratonia (confirmed with PAI and MAS)
- proxy consent
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supporting cushionsCushions were placed in a way that the head and four limbs were well supported, without leaving empty space between body and cushions or mattress. | Other | all participants |
| Harmonic techniquesHarmonic techniques (HT) is a group of manual techniques described by Lederman (2000).The goal of this techniques in this study was to reduce the muscle tone and additionally/subsequently increase the ROM. | Other | all participants |
Primary outcome
Change in muscle tone of biceps brachii and rectus femoris
Time frame: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)
Change in MyotonPRO measurement of intrinsic muscle tone of left and right biceps brachii and left and right rectus femoris
Change in maximal extension of elbow and knee
Time frame: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)
Change in goniometric measurement of maximal elbow and knee extension
Change in pain
Time frame: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)
Change in PACSLAC-D score (PACSLAC-D is a Dutch adaptation of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate): observation scale of pain during morning care. Scores range from 0 to 24, indicating the presence of various pain expressions. Higher scores indicate more pain.
Comparison of pain during morning care
Time frame: rated after morning care, daily during 2 weeks for each participant (control week and intervention week)
Comparison of PACSLAC-D scores during control week and harmonics week.PACSLAC-D is a Dutch adaptation of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate: observation scale of pain during morning care. Scores range from 0 to 24, indicating the presence of various pain expressions. Higher scores indicate more pain.
Comparison of comfort during morning care
Time frame: rated after morning care, daily during 2 weeks for each participant (control week and intervention week)
Comparison of score on comfort questionnaire 4 questions regarding comfort of morning care (both for caregiver as estimated for patient) between control week and harmonics week, as rated with a visual analogue scale (0-10, interpretation dependent on the question)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supporting cushions and Harmonic techniques in people with Dementia and Paratonia, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle tone of biceps brachii and rectus femoris (time frame: On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.