NCT03149458

Brief Summary

The majority of hemiparetic patients have balance disorders, which impact independence in daily living activities and walking. Conventional techniques used in rehabilitation improve balance but have shown no effects on dynamic balance required during walking. Recently dance is proposed to improve dynamic balance in older people and people with Parkinson's disease. Although many studies showed that dance is an effective activity to improve balance in these people, it has never been assessed in hemiparetic patients (except a case report). The aim of this study is to show that a dance program improves the balance of hemiparetic patients, compared to a control group. This randomized controlled study aims to include 40 hemiparetic patients who will perform a dance program (experimental group) or a upper-limb rehabilitation program (control group) for 8 one-hour sessions.

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

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

February 27, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

3.7 years

First QC Date

February 27, 2017

Last Update Submit

July 12, 2019

Conditions

Keywords

strokebalancedance

Outcome Measures

Primary Outcomes (1)

  • Timed up and Go

    get up, walk 3m, turn around and return sit down

    5min

Secondary Outcomes (1)

  • Berg Balance Scale

    10min

Study Arms (2)

Dance group

EXPERIMENTAL

dance program for 8 one-hour sessions.

Other: dance

control group

ACTIVE COMPARATOR

upper limb rehabilitation for 8 one-hour sessions.

Other: control

Interventions

danceOTHER

dance program

Dance group
controlOTHER

upper limb rehabilitation

control group

Eligibility Criteria

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

You may qualify if:

  • Patient who signed the consent letter
  • Male or female adults age ≥ 18 years,
  • Hemiparetic patient
  • Patient with balance disorders, able to walk alone and perform a U-turn, with or without technical assistance.

You may not qualify if:

  • Bilateral brain lesions, cerebellar syndrome
  • Other pathology or impairment that may interfere with the study such as visual, cardiovascular or other uncontrolled medical conditions
  • Major cognitive disorders not allowing the dance activity or the passing of evaluations
  • Behavioral disorders not allowing group workshops
  • Pregnant woman, breastfeeding
  • Non-affiliation to a social security scheme (beneficiary or beneficiary)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Raymond Poincaré Hospital- PMR Unit - Netter

Garches, 92380, France

RECRUITING

MeSH Terms

Conditions

ParesisStroke

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • François GENET, PhD

    Centre d'Investigation Clinique et Technologique 805

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

February 27, 2017

First Posted

May 11, 2017

Study Start

March 15, 2017

Primary Completion

November 30, 2020

Study Completion

January 1, 2021

Last Updated

July 15, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations