Gait and Balance of Diabetes Type 2 Patients
Gait and Balance of Diabetes Type 2 Patients
March, 2008
ClinicalTrials.gov
This study is currently recruiting participants.
Verified by University Hospital, Geneva, March 2008
Sponsors and Collaborators: University Hospital, Geneva
Maastricht University Medical Center
Swiss Federal Institute of Technology
EPFL Lausanne(CH)
Information provided by: University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT00637546
Purpose
Type 2 diabetes is one of the fastest growing public health problems in both developed and developing countries. It is estimated that the number of people with diabetes in the world will double in coming years, from 171 million in 2000 to 366 million in 2030.The role of physiotherapy in diabetic care is to reduce immobilisation effects, to maintain functional capacity and to minimise diabetes-related complications. The physiotherapist also has a role in providing advice about exercise and daily living activities. The fundamental principle of rehabilitation is to improve quality of life while diminishing the health care burden. By reducing the heightened risk of falling, the fall related injuries and the fear of falling one could improve quality of life in diabetic patients and reduce health care costs.
The goal of this study is to investigate the effectiveness of gait and balance training in pre frail subgroup diabetes patients. Our program is based on recommendations of Robertson et al.(2002) and Page et al.(2002) We randomly assign patients in a control group (no treatment) or in a treatment group. The treatment program consists of two group sessions per week over 12 weeks. Patients were encouraged to perform specific home exercises. After this 12-week program, patients were asked to continue their exercises. The effect of the treatment will be evaluated after the treatment program and after a 6-month follow up.
Condition Intervention Phase
Diabetes Type 2
Other: Physiotherapy
Phase II
Phase III
MedlinePlus related topics: Diabetes Exercise and Physical Fitness
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy
Further study details as provided by University Hospital, Geneva:
Primary Outcome Measures:
* Gait parameter: comfortable speed [ Time Frame: Before treatment / After treatment / 6 month follow up ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
* Other spatio temporal gait parameters and sagittal movement of lower limb [ Time Frame: Before Treatment/ After Treatment/ 6 month follow up ] [ Designated as safety issue: No ]
* Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum) [ Time Frame: Before Treatment / After Treatment / 6 month follow up ] [ Designated as safety issue: No ]
* Fear of falling (Falls efficacy scale) [ Time Frame: Before Treatment / After Treatment / 6 month follow up ] [ Designated as safety issue: No ]
Estimated Enrollment: 60
Study Start Date: September 2007
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A,1: Experimental
Physiotherapy
Other: Physiotherapy
Gait and Balance training based on recommendations of Robertson et al. and Page et al. (different balance control exercises; progression in consecutive stages: Sensimotor training, a static phase, a dynamic phase combined with functional tasks. The treatment takes place twice a week over 12 weeks. Patients were encouraged to perform specific home exercises.
Eligibility
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
* Past or present patient from the University Hospital in Geneva
* Diagnosed with diabetes by the medical doctor (glycaemia > 7 mmol on two different tests on an empty stomach)
* Presence of a peripheral neuropathy (vibration perception ≤ 4)
Exclusion Criteria:
* Patients with a foot ulcer at the moment of intake
* Patients with orthopaedic or chirurgical problems influencing gait parameters
* Patients with a non diabetic neuropathy (Charcot, alcohol, Thyroid dysfunction)
* Patients with neurological problems influencing gait parameters
* Patients with incapacity to walk without a walking aid
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00637546
Contacts
Contact: Lara E Allet, MPTSc 0041 79 601 35 91 h
Contact: Stéphane Armand, PhD 0041 22 372 78 27 stephane.armand@hcuge.ch
Locations
Switzerland
University Hospital of Geneva Recruiting
Geneva, Switzerland, 1205
Contact: Lara Allet, MPtSc 0041 79 601 35 91 lara.allet@hcuge.ch
Contact: Stéphane Armand, PhD 0041 22 732 78 27 stephane.armand@hcuge.ch
Principal Investigator: Lara E Allet, MPtSc
Sub-Investigator: Stéphane Armand, PhD
Sub-Investigator: Alain Golay, MD
Sub-Investigator: Rob A de Bie, PhD
Sub-Investigator: Eling B de Bruin, PhD
Sub-Investigator: Kamiar Aminian, PhD
Sub-Investigator: Dominique Monnin, DIP
Sponsors and Collaborators
University Hospital, Geneva
Maastricht University Medical Center
Swiss Federal Institute of Technology
EPFL Lausanne(CH)
Investigators
Principal Investigator: Lara E Allet, MPtSc University Hospital and University Geneva
More Information
Publications:
Allet L, Armand S, Golay A, Monnin D, de Bie RA, de Bruin ED. Gait characteristics of diabetic patients: a systematic review. Diabetes Metab Res Rev. 2008 Mar;24(3):173-91.
Responsible Party: University Hopsital Geneva ( Lara Allet (Mrs) )
Study ID Numbers: 06-305
First Received: March 11, 2008
Last Updated: March 11, 2008
ClinicalTrials.gov Identifier: NCT00637546
Health Authority: Switzerland: University Hospital Geneva
Keywords provided by University Hospital, Geneva:
Treatment
Efficacy
Diabetes
Gait
Balance
Study placed in the following topic categories:
Metabolic Diseases
Diabetic Neuropathies
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
ClinicalTrials.gov processed this record on December 10, 2008
