Short-term Effect of Positioning Cushions and Harmonic Techniques on Paratonia in Persons With Dementia
Primary Purpose
Dementia, Paratonia
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Supporting cushions
Harmonic techniques
Sponsored by
About this trial
This is an interventional treatment trial for Dementia focused on measuring harmonic techniques, supporting cushions, intervention
Eligibility Criteria
Inclusion Criteria:
- dementia (confirmed in medical file)
- presence of moderate to severe paratonia (confirmed with PAI and MAS)
- proxy consent
Exclusion Criteria:
-
Sites / Locations
- Vakgroep Revaki - Ghent University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
all participants
Arm Description
All participants received the same interventions, there were no subgroups interventions: supporting cushions and harmonic techniques
Outcomes
Primary Outcome Measures
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
Change in maximal extension of elbow and knee
Change in goniometric measurement of maximal elbow and knee extension
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.
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.
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03538405
Brief Title
Short-term Effect of Positioning Cushions and Harmonic Techniques on Paratonia in Persons With Dementia
Official Title
Short-term Effect of Positioning Cushions and Harmonic Techniques on Paratonia in Persons With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 24, 2016 (Actual)
Primary Completion Date
December 21, 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Paratonia
Keywords
harmonic techniques, supporting cushions, intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
all participants
Arm Type
Experimental
Arm Description
All participants received the same interventions, there were no subgroups interventions: supporting cushions and harmonic techniques
Intervention Type
Other
Intervention Name(s)
Supporting cushions
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Harmonic techniques
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in muscle tone of biceps brachii and rectus femoris
Description
Change in MyotonPRO measurement of intrinsic muscle tone of left and right biceps brachii and left and right rectus femoris
Time Frame
On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)
Title
Change in maximal extension of elbow and knee
Description
Change in goniometric measurement of maximal elbow and knee extension
Time Frame
On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)
Title
Change in pain
Description
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.
Time Frame
On each measurement moment (3 or 4 times a day, 3 different days, 2 weeks for each participant)
Title
Comparison of pain during morning care
Description
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.
Time Frame
rated after morning care, daily during 2 weeks for each participant (control week and intervention week)
Title
Comparison of comfort during morning care
Description
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)
Time Frame
rated after morning care, daily during 2 weeks for each participant (control week and intervention week)
Other Pre-specified Outcome Measures:
Title
diagnosis of paratonia
Description
Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)
Time Frame
for inclusion
Title
paratonia severity
Description
Rating of paratonia severity by means of the Modified Ashworth Scale (MAS). Resistance against passive movement of the limbs is rated. Scores: 0: Normal tone, passive movement no problem; 1: Mild paratonia, slight resistance in passive movement; 2: Moderate paratonia, enhanced resistance in passive movement; 3: Severe paratonia, severe resistance in passive movement; 4: Very severe paratonia, passive movement (almost) impossible. Participants with moderate to severe paratonia were included in this study, defined as presence of a MAS score of ≥2 in at least one limb
Time Frame
for inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
dementia (confirmed in medical file)
presence of moderate to severe paratonia (confirmed with PAI and MAS)
proxy consent
Exclusion Criteria:
-
Facility Information:
Facility Name
Vakgroep Revaki - Ghent University
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Short-term Effect of Positioning Cushions and Harmonic Techniques on Paratonia in Persons With Dementia
We'll reach out to this number within 24 hrs