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

• ClinicalTrials.gov Identifier: NCT03538405
• Recruitment Status: Completed
• First Posted: May 29, 2018
• Last Update Posted: May 31, 2018
• Sponsor: University Ghent
• Information provided by (Responsible Party): University Ghent

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.

Condition or disease	Intervention/treatment	Phase
Dementia; Paratonia	Other: Supporting cushions; Other: Harmonic techniques	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Short-term Effect of Positioning Cushions and Harmonic Techniques on Paratonia in Persons With Dementia
• Actual Study Start Date: April 24, 2016
• Actual Primary Completion Date: December 21, 2017
• Actual Study Completion Date: December 21, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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.
4. 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.
5. 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)

Other Outcome Measures:

1. diagnosis of paratonia [ Time Frame: for inclusion ]
   Paratonia Assessment Instrument, resistance against passive movements of the four limbs is evaluated (Hobbelen 2008)
2. paratonia severity [ Time Frame: for inclusion ]
   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

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations

Locations

Belgium

Vakgroep Revaki - Ghent University

Ghent, Belgium, 9000

Sponsors and Collaborators

University Ghent

More Information

• Responsible Party: University Ghent
• ClinicalTrials.gov Identifier: NCT03538405
• Other Study ID Numbers: EC/2016/0019
• First Posted: May 29, 2018
• Last Update Posted: May 31, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Ghent:

harmonic techniques; supporting cushions; intervention

Additional relevant MeSH terms:

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders