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

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538405
• Other study ID #: EC/2016/0019
• Status: Completed
• Phase: N/A
• Start date: April 24, 2016
• Est. completion date: December 21, 2017

Study information

• Verified date: May 2023
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 21, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• dementia (confirmed in medical file)

• presence of moderate to severe paratonia (confirmed with PAI and MAS)

• proxy consent

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Dementia
• Paratonia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Vakgroep Revaki - Ghent University	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	diagnosis of paratonia	Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)	for inclusion
Other	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
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)