Dance Workshop on Balance of Hemiparetic Patients (DanceStudio)
Primary Purpose
Hemiparesis
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dance
control
Sponsored by
About this trial
This is an interventional treatment trial for Hemiparesis focused on measuring stroke, balance, dance
Eligibility Criteria
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)
Sites / Locations
- Raymond Poincaré Hospital- PMR Unit - NetterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Dance group
control group
Arm Description
dance program for 8 one-hour sessions.
upper limb rehabilitation for 8 one-hour sessions.
Outcomes
Primary Outcome Measures
Timed up and Go
get up, walk 3m, turn around and return sit down
Secondary Outcome Measures
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
Full Information
NCT ID
NCT03149458
First Posted
February 27, 2017
Last Updated
July 12, 2019
Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches
1. Study Identification
Unique Protocol Identification Number
NCT03149458
Brief Title
Dance Workshop on Balance of Hemiparetic Patients
Acronym
DanceStudio
Official Title
Effects of a Dance Workshop on the Balance Abilities of Hemiparetic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2017 (Actual)
Primary Completion Date
November 30, 2020 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Investigation Clinique et Technologique 805
Collaborators
Fondation Garches
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiparesis
Keywords
stroke, balance, dance
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dance group
Arm Type
Experimental
Arm Description
dance program for 8 one-hour sessions.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
upper limb rehabilitation for 8 one-hour sessions.
Intervention Type
Other
Intervention Name(s)
dance
Intervention Description
dance program
Intervention Type
Other
Intervention Name(s)
control
Intervention Description
upper limb rehabilitation
Primary Outcome Measure Information:
Title
Timed up and Go
Description
get up, walk 3m, turn around and return sit down
Time Frame
5min
Secondary Outcome Measure Information:
Title
Berg Balance Scale
Description
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
Time Frame
10min
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
François GENET, PhD
Phone
+33 (1) 47 10 70 68
Email
francois.genet@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima IZEDAREN
Phone
+33 (1)47 10 44 49
Email
fatima.izedaren@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François GENET, PhD
Organizational Affiliation
Centre d'Investigation Clinique et Technologique 805
Official's Role
Principal Investigator
Facility Information:
Facility Name
Raymond Poincaré Hospital- PMR Unit - Netter
City
Garches
ZIP/Postal Code
92380
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Céline Bonnyaud, PhD
Phone
0033147107068
Email
celine.bonnyaud@aphp.fr
First Name & Middle Initial & Last Name & Degree
Alexandra Delarue, PT
Phone
0033147107068
Email
alexandra.delarue@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Dance Workshop on Balance of Hemiparetic Patients
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