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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03149458
Other study ID # 2016-A01876-45
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 15, 2017
Est. completion date January 1, 2021

Study information

Verified date July 2019
Source Centre d'Investigation Clinique et Technologique 805
Contact François GENET, PhD
Phone +33 (1) 47 10 70 68
Email francois.genet@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date January 1, 2021
Est. primary completion date November 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
dance
dance program
control
upper limb rehabilitation

Locations

Country Name City State
France Raymond Poincaré Hospital- PMR Unit - Netter Garches

Sponsors (2)

Lead Sponsor Collaborator
Centre d'Investigation Clinique et Technologique 805 Fondation Garches

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Timed up and Go get up, walk 3m, turn around and return sit down 5min
Secondary 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
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