NCT04101084

Brief Summary

Patients with dementia exhibit a wide range of behavioral symptoms which include mood disturbances (e.g depression, anxiety), behavior and activity disturbances (e.g agitation, aggression, wandering) and psychotic symptoms (e.g hallucinations and delusions). Behavioral disturbances are a major source of caregiver burden and an important contributor to the decision to admit AD patients to institutionalized long-term care. Among the innovative approaches, rocking chair therapy has been introduced as a potential means for reducing agitation in elderly with dementia. Only few studies evaluated the effect of this therapy on the behavioral symptoms in elderly with cognitive impairment. The results were promising, but not sufficiently significant. We propose to perform this study having as a main goal to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia. The secondary aim of the study will be the evaluation of psychoactive drugs use as well as pain killers. Cohen Mansfield agitation inventory will be employed for the pre- and post-therapy evaluation. Included subjects will be installed in groups of five, rocking chairs will be placed away from other residents in a semicircle in a corner of the dayroom. The therapy sessions will be held every afternoon, for two hours, under the supervision of the unit psychologist and a master's degree psychology student. During the daily session, each resident should be encouraged to actively rock to reach the goal of 60 minutes of rocking accumulated per day. The total duration of the therapy period will be 6 weeks. The use of pharmacological restraint (neuroleptics, anxiolytics) and pain killers will be evaluated before, during and after the six weeks therapy. The expected outcome is a reduction of agitation among elderly with dementia, as well as a reduction in the use of pharmacological restraint and pain killers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

August 8, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 25, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2024

Completed
Last Updated

May 26, 2026

Status Verified

May 1, 2026

Enrollment Period

3.5 years

First QC Date

August 8, 2019

Last Update Submit

May 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change of agitation

    Change from Baseline agitation at 6 weeks. The agitation will be evaluated using Cohen Mnasfiled agitation inventory a week before therapy, and the week after.

    At 6 weeks

Study Arms (1)

Rocking chair therapy

EXPERIMENTAL

Rocking sessions in a safe rocking chair for 2 hours daily for six weeks

Other: Therapy

Interventions

TherapyOTHER

Rocking sessions in a safe rocking chair for 2 hours daily for six weeks

Rocking chair therapy

Eligibility Criteria

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

You may qualify if:

  • resident of the EHPAD / LTC for at least 10 weeks
  • subject with cognitive impairment (MMSE \<24) documented according to DSM-5 criteria
  • with chronic behavioral disorders such as agitation
  • stable from a medical point of view
  • without restraint when not in bed
  • ability to touch the floor with the toes while sitting in the rocking chair
  • ability to sit securely in the rocking chair
  • ability to tolerate rocking chair
  • Ability to maintain active rocking for at least 5 minutes over a 30-minute period during the three pre-treatment trials
  • obligation for all patients to be affiliated to a social security scheme
  • signing of the informed consent by the patient and / or his legal representative

You may not qualify if:

  • Motor deficiency (example: after-effects of stroke ...) not allowing a secure installation in the chair or preventing an active rocking
  • ATCC with vestibular involvement that may lead to vertiginous seizures during rocking
  • Aging psychiatric pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice - Gérontology

Nice, Alpes-Maritime, 06100, France

Location

MeSH Terms

Conditions

Dementia

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • ZAAFRANE Malek, Ph

    Centre Hospitalier Universitaire de Nice

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: to evaluate the effect of the rocking chair therapy in agitation for home care residents with dementia.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2019

First Posted

September 24, 2019

Study Start

October 25, 2019

Primary Completion

April 18, 2023

Study Completion

April 18, 2024

Last Updated

May 26, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations