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Gait and Balance of Diabetes Type 2 Patients

This study has been completed.
Maastricht University Medical Center
Swiss Federal Institute of Technology
EPFL Lausanne(CH)
Information provided by:
University Hospital, Geneva Identifier:
First received: March 11, 2008
Last updated: January 13, 2010
Last verified: March 2009

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 Intervention Phase
Diabetes Type 2
Other: Physiotherapy
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 71
Study Start Date: September 2007
Study Completion Date: March 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A,1
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.
Other Name: Physical Therapy


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00637546

University Hospital of Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Maastricht University Medical Center
Swiss Federal Institute of Technology
EPFL Lausanne(CH)
Principal Investigator: Lara E Allet, MPtSc University Hospital and University Geneva
  More Information


Responsible Party: Lara Allet (Mrs), University Hopsital Geneva Identifier: NCT00637546     History of Changes
Other Study ID Numbers: 06-305
Study First Received: March 11, 2008
Last Updated: January 13, 2010

Keywords provided by University Hospital, Geneva:

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on April 28, 2017