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Completed

NCT Number: NCT07286825

Aromatherapy on Upper Limb Spasticity on Stroke Survivors

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).

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hong Kong Metropolitan University

Hong Kong

About this study

Study design This study employed a double-arm, pre- and post-test design. The study was conducted in two RCHEs in Hong Kong under a non-government organisation, Po Leung Kuk (PLK).

Participants We took reference from a pilot RCT on the effect of aromatherapy acupressure on hemiplegic shoulder and motor power among stroke patients recruited 30 patients (15 control and 15 intervention) (Shin & Lee, 2007). In our study, 30 elders aged 65 or above with post-stroke upper limbs spasticity were recruited from two RCHEs in Hong Kong and evenly divided in both control and intervention groups (please refer to CONSORT flowchart in Fig. 2). Among both groups, only two elders from the control group dropped out due to admission to hospital during the research period. Participants were considered eligible if: (1) he/she is communicable with either Chinese or English, and (2) suffering from upper-limb post-stroke spasticity. In addition, participants will be excluded if: (1) he/she is currently receiving aromatherapy massage therapies, (2) he/she has external wound on the massage areas.

An information sheet was given, and consent was sought from each carer and elder before the intervention. All elders and carers were free to withdraw consent at any time. Where possible, clarification on the specific area of withdrawal, but not obligatory. Previously collected data was use in the analyses.

Procedures A 10-minute massage was given on elders' 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 (8 sessions in total). Massage steps and rhythm and intensity are standardised for all subjects. Range of motion (ROM) and pain level was measured before and after each session of massage and psychosocial well-being will be measured at baseline and 4 weeks after the intervention.

Upper limb massage steps were standardized as follow:

Effleurage was done on the upper limbs and shoulders with mild pressure using hands, which mould themselves to the shape of the body being massaged (Price et al., 2020). 5-Step massage was done with sweet marjoram massage oil on both upper limbs as well as shoulders (as shown below). Whole massage process lasted for 10-15 minutes.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Combination Product

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.

plain fractionated coconut organic carrier oil

Combination Product

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.

Primary outcomes

  1. Range of motion (ROM) on shoulder joints

    Time frame: Before and after each massage session for 4 weeks in total

    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.

Secondary outcomes

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

    Time frame: Week 0 and Week 4 after completing all massage sessions

    The Chinese version of GAD-7 will be used for assessing the anxiety level severity in clinical practice (Spitzer et al., 2006). It consists of seven items; each item is scored from 0 to 3 with the total score ranges from 0 to 21. The internal consistency of the GAD-7 was excellent (Cronbach' α = .92).

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: Week 0 and Week 4 after completing all massage sessions

    The Chinese version of PHQ-9, which is widely used in different community settings for depression screening, will be used. PHQ-9 consists of nine-item depression module with internal consistency (Cronbach' α) of α =0.87.

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Official study title

The Effects of Aromatherapy on Upper Limb Spasticity and Psychosocial Well-being on Stroke Survivors in Residential Care Homes for the Elderly: A Pilot RCT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 16, 2025
Registry last updated
Dec 16, 2025

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

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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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