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Completed

NCT Number: NCT00637546

Gait and Balance of Diabetes Type 2 Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University Hospital of Geneva

Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physiotherapy

Other

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 names: Physical Therapy

Primary outcomes

  1. Gait parameter: comfortable speed

    Time frame: Before treatment / After treatment / 6 month follow up

Secondary outcomes

  1. Other spatio temporal gait parameters and sagittal movement of lower limb

    Time frame: Before Treatment/ After Treatment/ 6 month follow up

  2. Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum)

    Time frame: Before Treatment / After Treatment / 6 month follow up

  3. Fear of falling (Falls efficacy scale)

    Time frame: Before Treatment / After Treatment / 6 month follow up

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Ecole Polytechnique Fédérale de Lausanne
  • Maastricht University Medical Center
  • Swiss Federal Institute of Technology

Registry information

Official study title

Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Mar 18, 2008
Registry last updated
Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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