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

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 Overview

• Status: Completed
• Conditions: Dementia; Paratonia
• Intervention / Treatment: Other: Supporting cushions; Other: Harmonic techniques

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Vakgroep Revaki - Ghent University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: Supporting cushions; 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.; Other: Harmonic techniques; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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)	rated after morning care, daily during 2 weeks for each participant (control week and intervention week)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis of paratonia	Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)	for inclusion
paratonia severity	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	for inclusion

Collaborators and Investigators

• Sponsor: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2016
• Primary Completion (Actual): December 21, 2017
• Study Completion (Actual): December 21, 2017

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: intervention; harmonic techniques; supporting cushions
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: EC/2016/0019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No