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Completed

NCT Number: NCT03538405

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.

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Muscle Hypertonia Muscle Rigidity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurocognitive Disorders Neurologic Manifestations Neuromuscular Manifestations Paratonia Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vakgroep Revaki - Ghent University

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Supporting cushions

Other

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

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 29, 2018
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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