Gait and Balance of Diabetes Type 2 Patients
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|ClinicalTrials.gov Identifier: NCT00637546|
Recruitment Status : Completed
First Posted : March 18, 2008
Last Update Posted : January 14, 2010
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) The investigators 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 or disease||Intervention/treatment||Phase|
|Diabetes Type 2||Other: Physiotherapy||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||71 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||September 2008|
|Actual Study Completion Date :||March 2009|
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.
Other Name: Physical Therapy
- Gait parameter: comfortable speed [ Time Frame: Before treatment / After treatment / 6 month follow up ]
- Other spatio temporal gait parameters and sagittal movement of lower limb [ Time Frame: Before Treatment/ After Treatment/ 6 month follow up ]
- Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum) [ Time Frame: Before Treatment / After Treatment / 6 month follow up ]
- Fear of falling (Falls efficacy scale) [ Time Frame: Before Treatment / After Treatment / 6 month follow up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637546
|University Hospital of Geneva|
|Geneva, Switzerland, 1205|
|Principal Investigator:||Lara E Allet, MPtSc||University Hospital and University Geneva|