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Clinical Trials/NCT03538405
NCT03538405CompletedNot Applicable

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

University Ghent1 site in 1 country22 target enrollmentStarted: April 24, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Change in maximal extension of elbow and knee

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •dementia (confirmed in medical file)
  • •presence of moderate to severe paratonia (confirmed with PAI and MAS)
  • •proxy consent

Exclusion Criteria

  • Not provided

Arms & Interventions

all participants

Experimental

All participants received the same interventions, there were no subgroups interventions: supporting cushions and harmonic techniques

Intervention: Supporting cushions (Other)

all participants

Experimental

All participants received the same interventions, there were no subgroups interventions: supporting cushions and harmonic techniques

Intervention: Harmonic techniques (Other)

Outcomes

Primary Outcomes

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.

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

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)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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