NCT01613339

Brief Summary

Affected balance capacity is common after a stroke due to paresis and sensory disturbances. The affected balance capacity may cause walking disturbances, falls and decreased mobility. Balance may be improved by physical therapy. A possible method for balance training is body awareness therapy, that was introduced in Sweden by Jacques Dropsy and Gertrud Roxendal. Earlier body awareness therapy was mostly used in psychiatric care but in the recent years the method has been used for people with long-tern pain, amputations and multiple sclerosis. Body awareness therapy includes exercises in lying, sitting and standing. Focus of the exercises are awareness of one´s movement behaviour, breathing patterns, resources and limitations. Postural control is an essential part in the exercises. Body awareness therapy could be used for people with stroke as a way to improve postural control. The aim of this study is to investigate if balance training using body awareness therapy can improve balance and walking in people after stroke. The interventions consists of body awareness therapy once a week for 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Oct 2011

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 7, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

December 30, 2013

Completed
Last Updated

June 28, 2018

Status Verified

May 1, 2018

Enrollment Period

1.3 years

First QC Date

April 16, 2012

Results QC Date

June 7, 2013

Last Update Submit

May 7, 2018

Conditions

Keywords

strokepostural controlbody awareness therapy

Outcome Measures

Primary Outcomes (1)

  • Bergs Balance Scale

    Test of functional balance. Includes 14 items all graded 0-4 where 0 indicate larger impairment. Total score is used here, maximum 56 and minimum 0. The Berg balance scale was developed for older patients but is a much used meausure of dynamic and static functional balance.

    Change from baseline in Bergs balance scale at 9 weeks

Secondary Outcomes (2)

  • Timed Up and Go Test

    Change from baseline in Timed Up and Go test at 9 weeks

  • Activities-specific Balance Confidence Scale

    Change from baseline in Activities-specific Balance confidence scale at 9 weeks

Study Arms (2)

Body awareness therapy

EXPERIMENTAL
Other: Balance training using Body awareness therapy

Control

NO INTERVENTION

Interventions

Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Example of exercises are weight-balancing in standing and relaxation exercises.

Body awareness therapy

Eligibility Criteria

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

You may qualify if:

  • Diagnosed stroke more than 6 months ago. Walking capacity of 100 meter with or without assistive device.

You may not qualify if:

  • Medical or cognitive impairment that prohibits participating in the intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Health Care Centres

Örebro, Sweden

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Anette Forsberg
Organization
Orebro county council

Study Officials

  • Mialinn Arvidsson Lindvall, RPT, MSc

    Family Medicine Research Centre, Örebro county council

    PRINCIPAL INVESTIGATOR
  • Anette Forsberg, PhD

    Family Medicine Research Centre, Örebro county council

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, RPT

Study Record Dates

First Submitted

April 16, 2012

First Posted

June 7, 2012

Study Start

October 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

June 28, 2018

Results First Posted

December 30, 2013

Record last verified: 2018-05

Locations