Gait and Balance of Diabetes Type 2 Patients

Phase 2

Completed

• Conditions: Diabetes Type 2
• Interventions: Other: Physiotherapy

• Registration Number: NCT00637546
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2008-03-11
• Study First Submitted QC: 2008-03-11
• Study First Posted: 2008-03-18
• Primary Completion: 2008-09
• Status Verified: 2009-03
• Study Completion: 2009-03
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,1	Physiotherapy	Physiotherapy

Primary Outcome Measures

Name	Time	Method
Gait parameter: comfortable speed	Before treatment / After treatment / 6 month follow up

Secondary Outcome Measures

Name	Time	Method
Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum)	Before Treatment / After Treatment / 6 month follow up
Fear of falling (Falls efficacy scale)	Before Treatment / After Treatment / 6 month follow up
Other spatio temporal gait parameters and sagittal movement of lower limb	Before Treatment/ After Treatment/ 6 month follow up

Trial Locations

Locations (1)

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland