NCT02280980

Brief Summary

Individuals older than 60 years old, discharged after suffering brain stroke with referral to the rehabilitation outpatient clinic, will be assessed for orthostatic balance. Patients with positive Romberg test are invited to participate in the trial. Participants will be randomized to either the current rehabilitation protocol or to an supplemental intervention focused on oculomotor and gaze stability exercises to be applied at home for three weeks. Participants will be assessed with standardized, validated tools.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable stroke

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

July 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2014

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

5.5 years

First QC Date

October 30, 2014

Last Update Submit

March 24, 2020

Conditions

Keywords

StrokePostural BalanceOculomotor and Gaze Stability ExercisesRehabilitationPhysical therapyOutpatient

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale (BBS)

    Balance measure used in older people with impairment in balance function by assessing the performance of functional tasks

    Change on BBS from baseline up to three weeks of intervention

  • Timed Up and Go Test (TUG)

    simple test used to assess mobility and requires both static and dynamic balance

    Change on TUG from baseline up to three weeks of intervention

Study Arms (2)

Combined rehabilitation protocol

EXPERIMENTAL

The usual rehabilitation protocol in the physiotherapy department is supplemented with a three weeks home protocol of oculomotor and gaze stability exercises.

Other: Oculomotor and Gaze Stability Exercises

Usual rehabilitation protocol

NO INTERVENTION

The usual rehabilitation protocol in the physiotherapy department for patients after stroke.

Interventions

Daily oculomotor and gaze stability exercises, twice a day, for three weeks

Combined rehabilitation protocol

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke diagnosis 3 to 15 months before recruitment
  • Balance deficits (positive Romberg)
  • Patients able to walk 3 meters without assistance with or without an assistive device

You may not qualify if:

  • Balance problems previous to the index stroke
  • Severe osteo-articular lesions that compromise the ability to perform the proposed exercises
  • Previous exposure to oculomotor or gaze stability exercises

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • Berg, K., Wood-Dauphinée, S., Williams, J. & Gayton, D. (1989). Measuring balance in the elderly: preliminary development of an instrument. Physiotherapy Canada, 41, 304-311.

    BACKGROUND
  • Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.

    PMID: 1468055BACKGROUND
  • Carr JH, Shepherd RB, Nordholm L, Lynne D. Investigation of a new motor assessment scale for stroke patients. Phys Ther. 1985 Feb;65(2):175-80. doi: 10.1093/ptj/65.2.175.

    PMID: 3969398BACKGROUND
  • Dias et al (2009). Aplicação da Escala de Equilíbrio de Berg para verificação do equilíbrio de idosos em diferentes fases do envelhecimento. RBCEH, 6(2), 213-224.

    BACKGROUND
  • Geurts AC, de Haart M, van Nes IJ, Duysens J. A review of standing balance recovery from stroke. Gait Posture. 2005 Nov;22(3):267-81. doi: 10.1016/j.gaitpost.2004.10.002. Epub 2004 Dec 7.

    PMID: 16214666BACKGROUND
  • Hiengkaew V, Jitaree K, Chaiyawat P. Minimal detectable changes of the Berg Balance Scale, Fugl-Meyer Assessment Scale, Timed "Up & Go" Test, gait speeds, and 2-minute walk test in individuals with chronic stroke with different degrees of ankle plantarflexor tone. Arch Phys Med Rehabil. 2012 Jul;93(7):1201-8. doi: 10.1016/j.apmr.2012.01.014. Epub 2012 Apr 12.

    PMID: 22502805BACKGROUND
  • Morimoto H, Asai Y, Johnson EG, Lohman EB, Khoo K, Mizutani Y, Mizutani T. Effect of oculo-motor and gaze stability exercises on postural stability and dynamic visual acuity in healthy young adults. Gait Posture. 2011 Apr;33(4):600-3. doi: 10.1016/j.gaitpost.2011.01.016. Epub 2011 Feb 19.

    PMID: 21334899BACKGROUND
  • Correia A, Pimenta C, Alves M, Virella D. Better balance: a randomised controlled trial of oculomotor and gaze stability exercises to reduce risk of falling after stroke. Clin Rehabil. 2021 Feb;35(2):213-221. doi: 10.1177/0269215520956338. Epub 2020 Sep 9.

  • Pimenta C, Correia A, Alves M, Virella D. Effects of oculomotor and gaze stability exercises on balance after stroke: Clinical trial protocol. Porto Biomed J. 2017 May-Jun;2(3):76-80. doi: 10.1016/j.pbj.2017.01.003. Epub 2017 Feb 12.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Anabela Correia, Pt, MSc

    Centro Hospitalar de Lisboa Central

    PRINCIPAL INVESTIGATOR
  • Carla Pimenta, Pt, MSc

    Centro Hospitalar de Lisboa Central

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2014

First Posted

November 3, 2014

Study Start

July 1, 2014

Primary Completion

January 15, 2020

Study Completion

March 15, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

Patients are informed that their records are available to them.

Shared Documents
STUDY PROTOCOL, ICF