Diabetes Type 2Phase 2/3NCT00637546
Gait and Balance of Diabetes Type 2 Patients
A Phase 2/3 study testing Physiotherapy in people with Diabetes Type 2, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes Type 2
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2007to Mar 2009
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy
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.
- Conditions
- Diabetes Type 2
- Being tested
- Physiotherapy
- Keywords
- Treatment, Efficacy, Diabetes, Gait, Balance
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
Also called Physical Therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| A,1 | Experimental | Physiotherapy Receives: Other: Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait parameter: comfortable speed
Measured: Before treatment / After treatment / 6 month follow up
Secondary outcomes (3)
Other spatio temporal gait parameters and sagittal movement of lower limb
Measured: Before Treatment/ After Treatment/ 6 month follow up
Balance measures (Tinetti and Biodex balance Index, acceleration on sacrum)
Measured: Before Treatment / After Treatment / 6 month follow up
Fear of falling (Falls efficacy scale)
Measured: Before Treatment / After Treatment / 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Diabetes Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University Medical Center, Swiss Federal Institute of Technology, Ecole Polytechnique Fédérale de Lausanne
- Investigators
- Lara E Allet, MPtSc, Principal investigator, University Hospital and University Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00637546
- Sponsor's protocol ID
- 06-305
- Status last verified
- Mar 2009
- First submitted
- 11 Mar 2008
- Last updated
- 14 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Allet L, Armand S, Golay A, Monnin D, de Bie RA, de Bruin ED. Gait characteristics of diabetic patients: a systematic review. Diabetes Metab Res Rev. 2008 Mar-Apr;24(3):173-91. doi: 10.1002/dmrr.809.
PubMed 18232063Turcot K, Allet L, Golay A, Hoffmeyer P, Armand S. Investigation of standing balance in diabetic patients with and without peripheral neuropathy using accelerometers. Clin Biomech (Bristol). 2009 Nov;24(9):716-21. doi: 10.1016/j.clinbiomech.2009.07.003. Epub 2009 Aug 14.
PubMed 19683372Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, Staal JB, de Bruin ED. The gait and balance of patients with diabetes can be improved: a randomised controlled trial. Diabetologia. 2010 Mar;53(3):458-66. doi: 10.1007/s00125-009-1592-4. Epub 2009 Nov 17.
PubMed 19921145Allet L, Armand S, de Bie RA, Golay A, Pataky Z, Aminian K, de Bruin ED. Clinical factors associated with gait alterations in diabetic patients. Diabet Med. 2009 Oct;26(10):1003-9. doi: 10.1111/j.1464-5491.2009.02811.x.
PubMed 19900232Allet L, Armand S, de Bie RA, Pataky Z, Aminian K, Herrmann FR, de Bruin ED. Gait alterations of diabetic patients while walking on different surfaces. Gait Posture. 2009 Apr;29(3):488-93. doi: 10.1016/j.gaitpost.2008.11.012. Epub 2009 Jan 9.
PubMed 19138520Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, de Bruin ED. Reliability of diabetic patients' gait parameters in a challenging environment. Gait Posture. 2008 Nov;28(4):680-6. doi: 10.1016/j.gaitpost.2008.05.006. Epub 2008 Jun 25.
PubMed 18579384
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Specific Physiotherapy Group Treatment on Gait and Balance in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT00637546
- Acronym / sponsor ID
- 06-305
- Conditions
- Diabetes Type 2
- Keywords
- Treatment, Efficacy, Diabetes, Gait, Balance
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Maastricht University Medical Center, Swiss Federal Institute of Technology, Ecole Polytechnique Fédérale de Lausanne
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 18 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A,1 | Experimental | Other: PhysiotherapyPhysiotherapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhysiotherapyAlso: Physical TherapyGait 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 | A,1 |
Primary outcome
Gait parameter: comfortable speed
Time frame: Before treatment / After treatment / 6 month follow up
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2010.
- Background: PubMed 18232063Allet L, Armand S, Golay A, Monnin D, de Bie RA, de Bruin ED. Gait characteristics of diabetic patients: a systematic review. Diabetes Metab Res Rev. 2008 Mar-Apr;24(3):173-91. doi: 10.1002/dmrr.809.
- Background: PubMed 19683372Turcot K, Allet L, Golay A, Hoffmeyer P, Armand S. Investigation of standing balance in diabetic patients with and without peripheral neuropathy using accelerometers. Clin Biomech (Bristol). 2009 Nov;24(9):716-21. doi: 10.1016/j.clinbiomech.2009.07.003. Epub 2009 Aug 14.
- Results publication: PubMed 19921145Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, Staal JB, de Bruin ED. The gait and balance of patients with diabetes can be improved: a randomised controlled trial. Diabetologia. 2010 Mar;53(3):458-66. doi: 10.1007/s00125-009-1592-4. Epub 2009 Nov 17.
- Results publication: PubMed 19900232Allet L, Armand S, de Bie RA, Golay A, Pataky Z, Aminian K, de Bruin ED. Clinical factors associated with gait alterations in diabetic patients. Diabet Med. 2009 Oct;26(10):1003-9. doi: 10.1111/j.1464-5491.2009.02811.x.
- Results publication: PubMed 19138520Allet L, Armand S, de Bie RA, Pataky Z, Aminian K, Herrmann FR, de Bruin ED. Gait alterations of diabetic patients while walking on different surfaces. Gait Posture. 2009 Apr;29(3):488-93. doi: 10.1016/j.gaitpost.2008.11.012. Epub 2009 Jan 9.
- Results publication: PubMed 18579384Allet L, Armand S, de Bie RA, Golay A, Monnin D, Aminian K, de Bruin ED. Reliability of diabetic patients' gait parameters in a challenging environment. Gait Posture. 2008 Nov;28(4):680-6. doi: 10.1016/j.gaitpost.2008.05.006. Epub 2008 Jun 25.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lara E Allet, MPtSc principal investigator
University Hospital and University Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Physiotherapy in people with Diabetes Type 2, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait parameter: comfortable speed (time frame: Before treatment / After treatment / 6 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00637546, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2010.