Dance Workshop on Balance of Hemiparetic Patients (DanceStudio)

Effects of a Dance Workshop on the Balance Abilities of Hemiparetic Patients

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.

Study Overview

• Status: Unknown
• Conditions: Hemiparesis
• Intervention / Treatment: Other: dance; Other: control

Detailed Description

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. These activities are carried out in the form of a workshop and are already proposed in common practice in the service. They are carried out by the physiotherapists of the service. Patients are assigned in one of two study groups. It is specified that they will be able to carry out the program of the opposing group at the end of the study in order to limit the "disappointment" effect. The evaluations will be carried out at 4 and 8 weeks and will mainly rely on data of balance, function, quality of life and satisfaction

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: François GENET, PhD; Phone Number: +33 (1) 47 10 70 68; Email: francois.genet@aphp.fr
• Study Contact Backup: Name: Fatima IZEDAREN; Phone Number: +33 (1)47 10 44 49; Email: fatima.izedaren@aphp.fr

Study Locations

• France
  • Garches, France, 92380
    • Recruiting
    • Raymond Poincaré Hospital- PMR Unit - Netter
    • Contact: Céline Bonnyaud, PhD; Phone Number: 0033147107068; Email: celine.bonnyaud@aphp.fr
    • Contact: Alexandra Delarue, PT; Phone Number: 0033147107068; Email: alexandra.delarue@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Bilateral brain lesions, cerebellar syndrome
• Other pathology or impairment that may interfere with the study such as visual, cardiovascular or other uncontrolled medical conditions
• Patient who underwent surgery of the musculoskeletal system in The 6 months prior to inclusion
• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Dance group; dance program for 8 one-hour sessions.	Other: dance; dance program
ACTIVE_COMPARATOR: control group; upper limb rehabilitation for 8 one-hour sessions.	Other: control; upper limb rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and Go	get up, walk 3m, turn around and return sit down	5min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	clinical scale assessing balance. 14-item scale designed to measure balance of the older adult in a clinical setting. Scoring: A five-point scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Total Score = 56	10min

Collaborators and Investigators

• Sponsor: Centre d'Investigation Clinique et Technologique 805
• Collaborators: Fondation Garches

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 15, 2017
• Primary Completion (ANTICIPATED): November 30, 2020
• Study Completion (ANTICIPATED): January 1, 2021

Study Registration Dates

• First Submitted: February 27, 2017
• First Submitted That Met QC Criteria: May 9, 2017
• First Posted (ACTUAL): May 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: stroke; balance; dance
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: 2016-A01876-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No