Gait and Balance of Diabetes Type 2 Patients

This study has been completed.
Sponsor:
Collaborators:
Maastricht University Medical Center
Swiss Federal Institute of Technology
EPFL Lausanne(CH)
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00637546
First received: March 11, 2008
Last updated: January 13, 2010
Last verified: March 2009
  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) 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
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


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 ]

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
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.
Other Name: Physical Therapy

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637546

Locations
Switzerland
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)
Investigators
Principal Investigator: Lara E Allet, MPtSc University Hospital and University Geneva
  More Information

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

Keywords provided by University Hospital, Geneva:
Treatment
Efficacy
Diabetes
Gait
Balance

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 30, 2014