NCT02061371

Brief Summary

Evaluate the effectiveness of virtual therapy and conventional physiotherapy in spastic muscles of patients with sequelae of stroke.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 12, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

February 7, 2014

Last Update Submit

February 10, 2014

Conditions

Keywords

strokespasticityphysiotherapyvirtual reality

Outcome Measures

Primary Outcomes (1)

  • Espasticity

    It is believed that this study achieves positive results regarding the adequacy of muscle tone associated with musculoskeletal better performance, so that the muscles normotônicos gain strength and overcome the resistance of the hypertonic muscles, improving range of motion and harmony of the affected limbs, leading the consequent improvement of balance and gait, after application of virtual therapy.

    4 months

Study Arms (2)

virtual therapy

EXPERIMENTAL

Group 1 (G1) included 20 patients who will carry out the virtual therapy.

Other: virtual therapy

conventional physiotherapy

EXPERIMENTAL

Group 2 (G2) included 20 patients who hold conventional physiotherapy.

Other: conventional physiotherapy

Interventions

virtual therapy
conventional physiotherapy

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Medical referral for physiotherapy;
  • Maximum grade 2 spasticity in the upper and lower limbs according to the Modified Ashworth Scale;
  • Total passive range of elbow joint and knee to the movement of flexion and extension;
  • Independent ambulation, with or without support;
  • Cognitive preserved, being able to respond to the command of the examiner;
  • Least 6 months of injury;

You may not qualify if:

  • Active infection, and rash at the site of application of NMES;
  • Visual and hearing impairment;
  • Joint stiffness and musculoskeletal injuries of the elbow and knee,
  • Inability to interpret the therapeutic resources to be displayed;
  • Presenting lesions in areas of Wernick and drill;
  • Uncontrolled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lersm, Ip&D

São José dos Campos, São Paulo, 12244-000, Brazil

RECRUITING

MeSH Terms

Conditions

StrokeMuscle Spasticity

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Ana Carolina Borges, masters students

CONTACT

Mário Oliveira Lima, professor

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 12, 2014

Study Start

November 1, 2013

Primary Completion

February 1, 2014

Study Completion

December 1, 2014

Last Updated

February 12, 2014

Record last verified: 2014-01

Locations