NCT01883947

Brief Summary

The aim is to study effects of touch massage in the sub-acute phase after stroke in two main areas; general health and independence.The hypothesis are that; touch massage in the sub-acute phase after stroke decreases anxiety and pain, increases health related-quality of life, decrease physiological stress responses, increase sensorimotor function, decrease disability, and increase activity in sensorimotor areas and decrease redundant brain activity in motor-related areas.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

4.4 years

First QC Date

May 27, 2013

Last Update Submit

June 14, 2019

Conditions

Stroke

Keywords

StrokeMassageGeneral HealthIndependence

Outcome Measures

Primary Outcomes (1)

  • State-Trait Anxiety Scale

    Assessment of self-rated anxiety on two subscales. Traits are stable over time and not sensitive to occasional stressors. States are sensitive for occasional stressors assessing current emotional state

    2 month

Secondary Outcomes (12)

  • VAS

    2 weeks

  • Nottingham Health Profile

    2 weeks

  • ECG

    2 weeks

  • Salivary cortisol

    2 weeks

  • Blood pressure

    2 weeks

  • +7 more secondary outcomes

Study Arms (2)

Touch massage

EXPERIMENTAL

Intervention group will receive touch massage on hands and feet and the intervention will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks

Procedure: Touch massage

non-TENS

SHAM COMPARATOR

The sham treatment will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks

Other: non-TENS

Interventions

Touch massagePROCEDURE

Touch massage is a gentle massage with strokes on hands, arms, feet and legs with at pressure of 2.5 N which is more gentle than Swedish massage but harder than strokes performed with a brush. The speed of the strokes is about 1-5 cm/sec. During the massage, the subjects will lie on a bed. Intervention group will receive touch massage on hands and feet and the intervention will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks

Touch massage
non-TENSOTHER

Subjects in the control group will have sham treatment which is a non-active transcutaneous electrical nerve stimulation (non-TENS), while they lie in bed with electrodes attached to the skin of the affected arm. The device will be manipulated in a way so that no electrical impulses will reach the electrodes. During treatment, the masseur will remain in the room without initiating any conversation.

non-TENS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • stroke defined according to Trial of ORG 10172 in Acute Stroke Treatment (TOAST) and The Oxford Community Stroke Project Classification (OSPC),
  • impaired finger tapping on the affected side of the body,
  • the ability to flex the wrist 20° from substrate on affected side of the body

You may not qualify if:

  • cancerous tumors,
  • infections with fever,
  • neurologic or psychiatric disease,
  • alcohol or drug addiction,
  • conditions that impede communication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norrlands university hospital

Umeå, 90187, Sweden

Location

Related Publications (1)

  • Lamas K, Hager C, Lindgren L, Wester P, Brulin C. Does touch massage facilitate recovery after stroke? A study protocol of a randomized controlled trial. BMC Complement Altern Med. 2016 Feb 4;16:50. doi: 10.1186/s12906-016-1029-9.

    PMID: 26846253DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Kristina Lämås, PhD

    Umea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 27, 2013

First Posted

June 21, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2018

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)