Diabetic NeuropathiesNCT06459375
Effects of Modified Otago Versus Action Observation on Strength, Mobility and Fall Risk in Diabetic Neuropathy
A study testing modified otago exercises and Action Observation Training in people with Diabetic Neuropathies and Mobility, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the Effects of Modified Otago Exercise and Action Observation Training on strength, functional mobility and fall risk in patients with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Neuropathies, Mobility, Fall
- What is being tested?
- modified otago exercises and Action Observation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2024to 1 Sep 2024
- Phase
- Interventional
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with type 2 diabetes already diagnosed by physician from last 2 years
- Able to take instructions
Who cannot join
- Additional neurological problem Guillain barre syndrome, Parkinson disease, multiple sclerosis, other than neuropathy
- Participant with visual, vestibular system and auditory problems
- Participant with cardiovascular problem, cerebrovascular problem and epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Modified Otago Exercises and Action Observation Training on Strength, Functional Mobility and Fall Risk in Patients With Diabetic Neuropathy
To compare the Effects of Modified Otago Exercise and Action Observation Training on strength, functional mobility and fall risk in patients with diabetic neuropathy.
Read the detailed description
This study will be a randomized clinical trial. A total of 38 participants with diabetic neuropathy will be taken. By using non probability convenience sampling technique patients will be randomized and allocated into two intervention groups based on inclusion and exclusion criteria.Patients in group A will receive modified Otago exercises with conventional treatment.Patients in group B will receive Action Observation Training with conventional treatment.All participants will receive treatment of 40 minutes per session for 5 days a week for 8 weeks.The Michigan neuropathy screening instrument will be used for the assessment of diabetic neuropathy score.The strength,functional mobility and fall risk will be assessed by using 30 second chair stand test, Timed up and go test and fall efficacy scale.
- Conditions
- Diabetic Neuropathies, Mobility, Fall
- Being tested
- modified otago exercises, Action Observation Training
- Keywords
- Diabetic Neuropathies, Mobility, Fall
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified otago exercisesOther
patients will receive modified Otago exercises with conventional treatment.
Action Observation TrainingOther
Patients will receive Action Observation Training with conventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| Modified Otago exercise group | Experimental | patients in this group will receive modified Otago exercises with conventional treatment. Receives: Other: modified otago exercises |
| Action Observation Training group | Active comparator | patients in this group will receive Action Observation Training with conventional treatment. Receives: Other: Action Observation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Michigan neuropathy screening instrument (MNSI)
To determine neuropathy, Michigan neuropathy screening instrument (MNSI) developed by the researchers at the university of Michigan in 2000, used to diagnosed peripheral neuropathy. It includes two parts; section A is self-administered by the patient and assess the clinical symptoms through 15 Yes or No questions and section B is used on a clinical evaluation. The questionnaire inquiries about positive (pain, temperature sensation and tingling) and negative (numbness, sensory symptoms, cramps and muscle weakness, foot ulcer or cracks and amputation. Neuropathy can be defined as seven or more positive responses on the MNSI questionnaire. The test-retest reliability of the Turkish version of the MNSI was determined as 0.99 for the total score (intraclass correlation coefficient = 0.996)
Measured: 6 months
30 second chair stand test
30 second chair stand test assesses the leg strength and endurance in older adults.it is part of the stop elderly accidents, deaths, and injuries which was created by centers for Disease Control and Preventions a screening tool for senior belonging to the high fall risk group .it has excellent test-retest reliability r=0.89(95%confident interval 0.79-0.93)The test measures the number of times and older adults can get up from a chair with their arms crossed in front of their trunk(on the opposite shoulder crossed at the wrists)in 30 seconds.
Measured: 6 months
The timed up and go test
The timed up and go test is to identify mobility and balance. Patients sitting in a chair without armrest will be asked to stand up with the start command and walk the 3-meter distance, whose start and end points are specified before, turn around and sit on the chair again. The test will be repeated 3 times and the average time will be recorded. The TUG test showed excellent reliability (ICC>.95) The Timed -up and go‖ test showed good intrarater and interrater reliability (r = .93 ). less time taken by patient will be graded as good mobility
Measured: 6 months
Fall Efficacy Scale International:
Fall Efficacy Scale International:
It is a common test battery with 16 items that reveals the possibility of falling in patients. The total score ranges from 16 to 64, where 16 indicates NO concern and 64 indicates EXTREMELY concerned about falling during the performance of specific activities suggested by the questionnaire.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start1 May 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetic NeuropathiesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- after randomization patients will be divided into two groups through computer generated number programme. Patients in group A will receive modified Otago exercises with conventional treatment. Patients in group B will receive Action Observation Training with conventional treatment
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- zeest hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459375
- Sponsor's protocol ID
- REC/RCR & AHS/23/0283
- Status last verified
- Sep 2024
- First submitted
- 11 Jun 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ferreira JP, Sartor CD, Leal AM, Sacco IC, Sato TO, Ribeiro IL, Soares AS, Cunha JE, Salvini TF. The effect of peripheral neuropathy on lower limb muscle strength in diabetic individuals. Clin Biomech (Bristol). 2017 Mar;43:67-73. doi: 10.1016/j.clinbiomech.2017.02.003. Epub 2017 Feb 9.
PubMed 28213167Vratna E, Husakova J, Jarosikova R, Dubsky M, Woskova V, Bem R, Jirkovska A, Kralova K, Pyskova B, Lanska V, Fejfarova V. Effects of a 12-Week Interventional Exercise Programme on Muscle Strength, Mobility and Fitness in Patients With Diabetic Foot in Remission: Results From BIONEDIAN Randomised Controlled Trial. Front Endocrinol (Lausanne). 2022 Jul 5;13:869128. doi: 10.3389/fendo.2022.869128. eCollection 2022.
PubMed 35865313Van Eetvelde BLM, Lapauw B, Proot P, Vanden Wyngaert K, Celie B, Cambier D, Calders P. The impact of sensory and/or sensorimotor neuropathy on lower limb muscle endurance, explosive and maximal muscle strength in patients with type 2 diabetes mellitus. J Diabetes Complications. 2020 Jun;34(6):107562. doi: 10.1016/j.jdiacomp.2020.107562. Epub 2020 Feb 24.
PubMed 32122790
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Modified Otago Exercises and Action Observation Training on Strength, Functional Mobility and Fall Risk in Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT06459375
- Acronym / sponsor ID
- REC/RCR & AHS/23/0283
- Conditions
- Diabetic Neuropathies, Mobility, Fall
- Keywords
- Diabetic Neuropathies, Mobility, Fall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 14 Jun 2024 (actual)
- 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.
To compare the Effects of Modified Otago Exercise and Action Observation Training on strength, functional mobility and fall risk in patients with diabetic neuropathy.
Detailed description
This study will be a randomized clinical trial. A total of 38 participants with diabetic neuropathy will be taken. By using non probability convenience sampling technique patients will be randomized and allocated into two intervention groups based on inclusion and exclusion criteria.Patients in group A will receive modified Otago exercises with conventional treatment.Patients in group B will receive Action Observation Training with conventional treatment.All participants will receive treatment of 40 minutes per session for 5 days a week for 8 weeks.The Michigan neuropathy screening instrument will be used for the assessment of diabetic neuropathy score.The strength,functional mobility and fall risk will be assessed by using 30 second chair stand test, Timed up and go test and fall efficacy scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- after randomization patients will be divided into two groups through computer generated number programme. Patients in group A will receive modified Otago exercises with conventional treatment. Patients in group B will receive Action Observation Training with conventional treatment
| Arm | Type | Receives |
|---|---|---|
| Modified Otago exercise group | Experimental | Other: modified otago exercisespatients in this group will receive modified Otago exercises with conventional treatment. |
| Action Observation Training group | Active comparator | Other: Action Observation Trainingpatients in this group will receive Action Observation Training with conventional treatment. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals with type 2 diabetes already diagnosed by physician from last 2 years
- Able to take instructions
Key exclusion criteria (3 listed)
- Additional neurological problem Guillain barre syndrome, Parkinson disease, multiple sclerosis, other than neuropathy
- Participant with visual, vestibular system and auditory problems
- Participant with cardiovascular problem, cerebrovascular problem and epilepsy
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 |
|---|---|---|
| modified otago exercisespatients will receive modified Otago exercises with conventional treatment. | Other | Modified Otago exercise group |
| Action Observation TrainingPatients will receive Action Observation Training with conventional treatment. | Other | Action Observation Training group |
Primary outcome
Michigan neuropathy screening instrument (MNSI)
Time frame: 6 months
To determine neuropathy, Michigan neuropathy screening instrument (MNSI) developed by the researchers at the university of Michigan in 2000, used to diagnosed peripheral neuropathy. It includes two parts; section A is self-administered by the patient and assess the clinical symptoms through 15 Yes or No questions and section B is used on a clinical evaluation. The questionnaire inquiries about positive (pain, temperature sensation and tingling) and negative (numbness, sensory symptoms, cramps and muscle weakness, foot ulcer or cracks and amputation. Neuropathy can be defined as seven or more positive responses on the MNSI questionnaire. The test-retest reliability of the Turkish version of the MNSI was determined as 0.99 for the total score (intraclass correlation coefficient = 0.996)
30 second chair stand test
Time frame: 6 months
30 second chair stand test assesses the leg strength and endurance in older adults.it is part of the stop elderly accidents, deaths, and injuries which was created by centers for Disease Control and Preventions a screening tool for senior belonging to the high fall risk group .it has excellent test-retest reliability r=0.89(95%confident interval 0.79-0.93)The test measures the number of times and older adults can get up from a chair with their arms crossed in front of their trunk(on the opposite shoulder crossed at the wrists)in 30 seconds.
The timed up and go test
Time frame: 6 months
The timed up and go test is to identify mobility and balance. Patients sitting in a chair without armrest will be asked to stand up with the start command and walk the 3-meter distance, whose start and end points are specified before, turn around and sit on the chair again. The test will be repeated 3 times and the average time will be recorded. The TUG test showed excellent reliability (ICC>.95) The Timed -up and go‖ test showed good intrarater and interrater reliability (r = .93 ). less time taken by patient will be graded as good mobility
Fall Efficacy Scale International:
Time frame: 6 months
Fall Efficacy Scale International: It is a common test battery with 16 items that reveals the possibility of falling in patients. The total score ranges from 16 to 64, where 16 indicates NO concern and 64 indicates EXTREMELY concerned about falling during the performance of specific activities suggested by the questionnaire.
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 19 Sep 2024.
- Background: PubMed 28213167Ferreira JP, Sartor CD, Leal AM, Sacco IC, Sato TO, Ribeiro IL, Soares AS, Cunha JE, Salvini TF. The effect of peripheral neuropathy on lower limb muscle strength in diabetic individuals. Clin Biomech (Bristol). 2017 Mar;43:67-73. doi: 10.1016/j.clinbiomech.2017.02.003. Epub 2017 Feb 9.
- Background: PubMed 35865313Vratna E, Husakova J, Jarosikova R, Dubsky M, Woskova V, Bem R, Jirkovska A, Kralova K, Pyskova B, Lanska V, Fejfarova V. Effects of a 12-Week Interventional Exercise Programme on Muscle Strength, Mobility and Fitness in Patients With Diabetic Foot in Remission: Results From BIONEDIAN Randomised Controlled Trial. Front Endocrinol (Lausanne). 2022 Jul 5;13:869128. doi: 10.3389/fendo.2022.869128. eCollection 2022.
- Background: PubMed 32122790Van Eetvelde BLM, Lapauw B, Proot P, Vanden Wyngaert K, Celie B, Cambier D, Calders P. The impact of sensory and/or sensorimotor neuropathy on lower limb muscle endurance, explosive and maximal muscle strength in patients with type 2 diabetes mellitus. J Diabetes Complications. 2020 Jun;34(6):107562. doi: 10.1016/j.jdiacomp.2020.107562. Epub 2020 Feb 24.
- Individual participant dataSharing planned: No
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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.
zeest hashmi, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified otago exercises and Action Observation Training in people with Diabetic Neuropathies and Mobility, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 3 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 19 Sep 2024. 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 Pakistan. 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.
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?
Michigan neuropathy screening instrument (MNSI) (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT06459375, which also lists 3 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 19 Sep 2024.