NCT07286825

Brief Summary

This study employed a double-arm, pre- and post-test design. Stroke survivors aged 65 or above with post-stroke upper limbs spasticity were recruited from two RCHEs in Hong Kong between February and June 2025, and were divided into control and intervention groups. 10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks. The range of motion (ROM) of the upper limbs in three planes, i.e., abduction, flexion and extension and pain level and blood pressure were assessed before and after each massage session. Psychosocial well-being of elders was assessed at baseline and 4 weeks post-intervention using Generalised Anxiety Disorder (GAD-7) and Patient Health Questionnaire (PHQ-9).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 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

Study Start

First participant enrolled

February 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 21, 2025

Last Update Submit

December 13, 2025

Conditions

Keywords

aromatherapy massagestroke survivorsupper limb spasticity

Outcome Measures

Primary Outcomes (1)

  • Range of motion (ROM) on shoulder joints

    Range of motion (ROM) will be assessed on shoulder joints as the primary outcome. The shoulder complex consists of four joints: the glenohumeral (GH), sternoclavicular (SC), acromioclavicular (AC) and scapulothoracic joints. The ROM of shoulder requires coordinated motion of all these joint. To evaluate the functional ROM of the shoulder, a goniometer will be used for measuring the passive or active ROM values (degrees) before and after each week of massage for 4 weeks in total. Abduction, flexion and extension ROM will be measured.

    Before and after each massage session for 4 weeks in total

Secondary Outcomes (2)

  • The Chinese Version of Generalised Anxiety Disorder (GAD-7)

    Week 0 and Week 4 after completing all massage sessions

  • Patient Health Questionnaire (PHQ-9)

    Week 0 and Week 4 after completing all massage sessions

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil

Combination Product: massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil

Control group

ACTIVE COMPARATOR

using massage oil with plain fractionated coconut organic carrier oil

Combination Product: plain fractionated coconut organic carrier oil

Interventions

10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using plain fractionated coconut organic carrier oil as massage oil.

Control group

10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil.

Intervention group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • he/she is communicable with either Chinese or English, and
  • suffering from upper-limb post-stroke spasticity

You may not qualify if:

  • he/she is currently receiving aromatherapy massage therapies
  • he/she has external wound on the massage areas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hong Kong Metropolitan University

Hong Kong, Hong Kong

Location

MeSH Terms

Interventions

Massage

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Sze Ki Veronica LAI, Dr

    School of Nursing and Health Studies, Hong Kong Metropolitan Universit

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are masked for the ingredient of massage oil.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 21, 2025

First Posted

December 16, 2025

Study Start

February 1, 2025

Primary Completion

July 31, 2025

Study Completion

November 20, 2025

Last Updated

December 16, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

The researchers will guarantee full confidentiality. All data will be kept 2 years after the project completion date. All soft copies of data will be destroyed by reformatting the disk (destroying everything on it). Hard copies will be destroyed by shredding then cross shredding.

Locations