NCT03538405

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 24, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
Last Updated

May 10, 2023

Status Verified

May 1, 2023

Enrollment Period

1.7 years

First QC Date

April 17, 2018

Last Update Submit

May 9, 2023

Conditions

DementiaParatonia

Keywords

harmonic techniquessupporting cushionsintervention

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

  • diagnosis of paratonia

    for inclusion

  • paratonia severity

    for inclusion

Study Arms (1)

all participants

EXPERIMENTAL

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

Other: Supporting cushionsOther: Harmonic techniques

Interventions

Supporting cushionsOTHER

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.

all participants
Harmonic techniquesOTHER

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.

all participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vakgroep Revaki - Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

DementiaMuscle Rigidity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

May 29, 2018

Study Start

April 24, 2016

Primary Completion

December 21, 2017

Study Completion

December 21, 2017

Last Updated

May 10, 2023

Record last verified: 2023-05

Locations

BE(1)