NCT02250040

Brief Summary

The purpose of this study was to identify and evaluate the effect of a new protocol of physiotherapy to retrain walking ability after stroke in subjects older than fifty-five. This protocol was composed of specific, clearly defined and reproducible techniques, based on clinical and functional criteria.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Mar 2011

Typical duration for not_applicable stroke

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

March 1, 2011

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
Last Updated

September 26, 2014

Status Verified

September 1, 2014

Enrollment Period

3.1 years

First QC Date

April 2, 2014

Last Update Submit

September 25, 2014

Conditions

Stroke

Keywords

StrokeRehabilitationPhysiotherapyFunctional Recovery

Outcome Measures

Primary Outcomes (1)

  • Barthel Index

    up to 6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

Conventional physiotherapy for stroke.

Other: Conventional physiotherapy

Target group

EXPERIMENTAL

Techniques based on patients' functional level were added.

Other: Conventional physiotherapyOther: Techniques based on patients' functional level were added.

Interventions

Conventional physiotherapyOTHER

Physiotherapy techniques that included muscle training, stretching and endurance.

Control groupTarget group
Techniques based on patients' functional level were added.OTHER

The added techniques aimed to improve balance and movement dissociation.

Target group

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having suffered a single stroke episode with residual hemiparesis
  • Being candidate to begin a rehabilitation programme
  • Being able to walk before suffering the stroke
  • Having the ability to understand and follow simple instructions
  • Being hemodynamically stable within the first week after stroke

You may not qualify if:

  • Poor vital prognosis
  • Pathologies or disorders hampering the development of the study such as: blindness, prosthetics, sensory disorders, severe cognitive impairment and so on
  • Absence of motor impairments after stroke
  • Pre-stroke disorders that affected the ability to walk

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital La Fe

Valencia, Valencia, 46009, Spain

Location

Related Publications (1)

  • Sanchez-Sanchez ML, Belda-Lois JM, Mena-Del Horno S, Viosca-Herrero E, Igual-Camacho C, Gisbert-Morant B. A new methodology based on functional principal component analysis to study postural stability post-stroke. Clin Biomech (Bristol). 2018 Jul;56:18-26. doi: 10.1016/j.clinbiomech.2018.05.003. Epub 2018 May 5.

    PMID: 29775954DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Enrique Viosca-Herrero, PhD

    Hospital Universitario La Fe

    STUDY DIRECTOR

  • Juan-Manuel Belda-Lois, PhD

    Instituto de Biomecanica de Valencia

    STUDY DIRECTOR

  • Celedonia Igual-Camacho, PhD

    University of Valencia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DPT

Study Record Dates

First Submitted

April 2, 2014

First Posted

September 26, 2014

Study Start

March 1, 2011

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

September 26, 2014

Record last verified: 2014-09

Locations

ES(1)