Diabetic Peripheral NeuropathyNCT05565924
Alter-G Training on Gait and Balance in Diabetic Neuropathy Patients
A study testing Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks., Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. and Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. in people with Diabetic Peripheral Neuropathy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
Trial summary
Diabetic Peripheral Neuropathy and associated complications became globally serious arousing health problems. Aim: To evaluate the effect of Antigravity treadmill training on gait performance and functional balance in patients with Diabetic Peripheral Neuropathy. Design: Single-blinded randomized controlled trial. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Diabetic Peripheral Neuropathy
- What is being tested?
- Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks., Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. and Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 2 Jan 2022to 8 Jun 2022
- 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 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elderly with diabetic polyneuropathy.
- Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated hemoglobin (HbA1c) levels between 7 and 11 and fasting glucose levels ranging from 7.0 -11.1 mmol/L.
- Treated only with oral anti-diabetic agents (not taking insulin), Pharmacological treatment had to be stable for at least 3 months before the study.
- Able to walk independently with or without an assistive device.
- Scored 19 points or less in the "dynamic gait index.
Who cannot join
- Type 1 Diabetes Mellitus,
- Patient with malnutrition (Body mass index < 21 kg/m2 or with recent weight loss > 5% body weight in the last month or > 10% in six months).
- Patients With any severe chronic or uncontrolled comorbid condition such as recent myocardial infarction, unstable angina, acute congestive heart failure, third-degree heart block, and uncontrolled arrhythmia.
- Patients will be excluded also if they have abnormal skin integrity e.g. wounds or scar tissues or are on other complementary treatments.
- History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Antigravity Treadmill Training on the Gait Performance and Functional Balance in Patients With Diabetic Peripheral Neuropathy. Randomized Controlled Trial
Diabetic Peripheral Neuropathy and associated complications became globally serious arousing health problems.
Aim: To evaluate the effect of Antigravity treadmill training on gait performance and functional balance in patients with Diabetic Peripheral Neuropathy.
Read more
Design: Single-blinded randomized controlled trial. Setting: Outpatient rehabilitation unit. Population: Sixty-eight eligible participants with Diabetic Peripheral Neuropathy were randomly allocated to Five groups: group-A (100% weight-bearing; n=14), group-B (70% weight-bearing; n=13), group-C (50% weight-bearing; n=14), group-D (30% weight-bearing; n=13), group-E (control group; n=14).
Methods: Participants in study groups A, B, C, and D received moderate intensity (50-70% heart rate reserve) aerobic exercise training program on the antigravity treadmill (AlterG, Inc., Fremont, CA, USA) 3 times/week for 12-weeks. The gait performance (using the dynamic gait index) and the functional balance (using the Berg balance scale) variables were evaluated at 3-time points: baseline (evaluation-1), after 12 training weeks (evaluation-2), and 3 months post-training cessation (evaluation-3).
Read the detailed description
Diabetic Peripheral neuropathy is the most common serious diabetes-related complication affecting more than one-third of patients with diabetes especially those with type 2 diabetes. Diabetic Peripheral neuropathy is defined as the existence of clinical indicators of neural dysfunction after excluding other causes in patients with diabetes and is usually affecting the sensory nerves before the motor ones, following the distal to proximal pattern distribution. Type 2 diabetes-related microangiopathy, neural ischemia, and demyelination are the commonly encountered pathophysiological endpoints responsible for Diabetic Peripheral neuropathy-related neural lesions. The Diabetic Peripheral neuropathy-related proprioceptive inputs impairments further predispose patients to frequently disturbed static and dynamic balance as well as impaired gait performance. Controversy existed regarding the efficacy of the weight-support aerobic exercise training on the locomotion, gait, and functional variables in patients with Diabetic Peripheral neuropathy. Researchers initially thought that weight-bearing exercise training is more beneficial in improving physical function than non-weight-bearing exercise training in patients with Diabetic Peripheral neuropathy. Few studies reported non-significant functional effects of the increased weight support, while others reported beneficial effects of the partial weight off-loading aerobic exercise training on the gait, balance, and functional performance in patients with Diabetic Peripheral neuropathy.
- Conditions
- Diabetic Peripheral Neuropathy
- Being tested
- Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks., Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks., Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks., Group- D (30% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks., Group- E; Control group
- Keywords
- Diabetic neuropathy, Gait, Balance
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.Other
Also called Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Moderate-intensity aerobic exercise training on the antigravity treadmill (100% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).
Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.Other
Also called Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Moderate-intensity aerobic exercise training on the antigravity treadmill (70% weight-bearing) plus medications plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)
Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.Other
Also called Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Moderate-intensity aerobic exercise training on the antigravity treadmill (50% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)
Group- D (30% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.Other
Also called Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Moderate-intensity aerobic exercise training on the antigravity treadmill (30% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).
Group- E; Control groupOther
Also called Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Control: No aerobic exercise training on the antigravity treadmill, but only medications (Biguanide alone or "Sulfonylureas plus Biguanide combination) throughout the study.
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Experimental | This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill (100% weight-bearing; n=14) 3 times/week for 12-weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). Receives: Other: Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. |
| Group-B | Experimental | This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training (70% weight-bearing; n=13) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) 3 times/week for 12 weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). Receives: Other: Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. |
| Group-C | Experimental | This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training (50% weight-bearing; n=14) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA), 3 times/week for 12 weeks plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). Receives: Other: Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. |
| group-D (30% weight-bearing; n=13) | Experimental | This group received moderate-intensity aerobic exercise training (30% weight-bearing; n=13) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) 3 times/week for 12 weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). Receives: Other: Group- D (30% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. |
| group-E (control group; n=14) | Sham comparator | Served as a control group and participated in no aerobic exercise training on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) during the study, but received oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). Receives: Other: Group- E; Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gait performance
The gait performance (evaluated using the dynamic gait index). The dynamic gait index is composed of eight items/ tasks. According to the participant's performance; each item is scored on a 4-points ordinal scale from 0 to 3; with "0" indicating the worst achievement (severe impairment) while "3" represents the best score (normal performance).
Measured: 12-weeks
The functional balance
The functional balance (evaluated using the Berg balance scale). the Berg balance scale constitutes 14 functional tasks, with each task score ranging from "0 to 4" where "0" indicates the lowest level of function; while "4" indicates the independent performance of the task.
Measured: 12-weeks
Secondary outcomes (1)
Fasting blood glucose level
Fasting blood glucose level
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start2 Jan 2022
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Abdelaal, Umm Al-Qura University
- Investigators
- Ashraf Abdelaal, Principal investigator, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565924
- Sponsor's protocol ID
- 13-MED1319-10_IR1
- Status last verified
- Sep 2022
- First submitted
- 10 Jun 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Antigravity Treadmill Training on the Gait Performance and Functional Balance in Patients With Diabetic Peripheral Neuropathy. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05565924
- Acronym / sponsor ID
- 13-MED1319-10_IR1
- Conditions
- Diabetic Peripheral Neuropathy
- Keywords
- Diabetic neuropathy, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 2 Jan 2022 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 4 Oct 2022 (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.
Diabetic Peripheral Neuropathy and associated complications became globally serious arousing health problems.
Aim: To evaluate the effect of Antigravity treadmill training on gait performance and functional balance in patients with Diabetic Peripheral Neuropathy.
Design: Single-blinded randomized controlled trial. Setting: Outpatient rehabilitation unit. Population: Sixty-eight eligible participants with Diabetic Peripheral Neuropathy were randomly allocated to Five groups: group-A (100% weight-bearing; n=14), group-B (70% weight-bearing; n=13), group-C (50% weight-bearing; n=14), group-D (30% weight-bearing; n=13), group-E (control group; n=14).
Methods: Participants in study groups A, B, C, and D received moderate intensity (50-70% heart rate reserve) aerobic exercise training program on the antigravity treadmill (AlterG, Inc., Fremont, CA, USA) 3 times/week for 12-weeks. The gait performance (using the dynamic gait index) and the functional balance (using the Berg balance scale) variables were evaluated at 3-time points: baseline (evaluation-1), after 12 training weeks (evaluation-2), and 3 months post-training cessation (evaluation-3).
Detailed description
Diabetic Peripheral neuropathy is the most common serious diabetes-related complication affecting more than one-third of patients with diabetes especially those with type 2 diabetes. Diabetic Peripheral neuropathy is defined as the existence of clinical indicators of neural dysfunction after excluding other causes in patients with diabetes and is usually affecting the sensory nerves before the motor ones, following the distal to proximal pattern distribution. Type 2 diabetes-related microangiopathy, neural ischemia, and demyelination are the commonly encountered pathophysiological endpoints responsible for Diabetic Peripheral neuropathy-related neural lesions. The Diabetic Peripheral neuropathy-related proprioceptive inputs impairments further predispose patients to frequently disturbed static and dynamic balance as well as impaired gait performance. Controversy existed regarding the efficacy of the weight-support aerobic exercise training on the locomotion, gait, and functional variables in patients with Diabetic Peripheral neuropathy. Researchers initially thought that weight-bearing exercise training is more beneficial in improving physical function than non-weight-bearing exercise training in patients with Diabetic Peripheral neuropathy. Few studies reported non-significant functional effects of the increased weight support, while others reported beneficial effects of the partial weight off-loading aerobic exercise training on the gait, balance, and functional performance in patients with Diabetic Peripheral neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group-A | Experimental | Other: Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill (100% weight-bearing; n=14) 3 times/week for 12-weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). |
| Group-B | Experimental | Other: Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training (70% weight-bearing; n=13) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) 3 times/week for 12 weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). |
| Group-C | Experimental | Other: Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.This group received moderate-intensity (50-70% heart rate reserve) aerobic exercise training (50% weight-bearing; n=14) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA), 3 times/week for 12 weeks plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). |
| group-D (30% weight-bearing; n=13) | Experimental | Other: Group- D (30% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.This group received moderate-intensity aerobic exercise training (30% weight-bearing; n=13) on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) 3 times/week for 12 weeks, plus oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). |
| group-E (control group; n=14) | Sham comparator | Other: Group- E; Control groupServed as a control group and participated in no aerobic exercise training on the antigravity treadmill (AlterG Pro 200, AlterG Inc, California, USA) during the study, but received oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination"). |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Elderly with diabetic polyneuropathy.
- Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated hemoglobin (HbA1c) levels between 7 and 11 and fasting glucose levels ranging from 7.0 -11.1 mmol/L.
- Treated only with oral anti-diabetic agents (not taking insulin), Pharmacological treatment had to be stable for at least 3 months before the study.
- Able to walk independently with or without an assistive device.
- Scored 19 points or less in the "dynamic gait index.
Key exclusion criteria (5 listed)
- Type 1 Diabetes Mellitus,
- Patient with malnutrition (Body mass index < 21 kg/m2 or with recent weight loss > 5% body weight in the last month or > 10% in six months).
- Patients With any severe chronic or uncontrolled comorbid condition such as recent myocardial infarction, unstable angina, acute congestive heart failure, third-degree heart block, and uncontrolled arrhythmia.
- Patients will be excluded also if they have abnormal skin integrity e.g. wounds or scar tissues or are on other complementary treatments.
- History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems).
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 |
|---|---|---|
| Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.Also: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").Moderate-intensity aerobic exercise training on the antigravity treadmill (100% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination). | Other | Group-A |
| Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.Also: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").Moderate-intensity aerobic exercise training on the antigravity treadmill (70% weight-bearing) plus medications plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination) | Other | Group-B |
| Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.Also: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").Moderate-intensity aerobic exercise training on the antigravity treadmill (50% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination) | Other | Group-C |
| Group- D (30% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks.Also: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").Moderate-intensity aerobic exercise training on the antigravity treadmill (30% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination). | Other | group-D (30% weight-bearing; n=13) |
| Group- E; Control groupAlso: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").Control: No aerobic exercise training on the antigravity treadmill, but only medications (Biguanide alone or "Sulfonylureas plus Biguanide combination) throughout the study. | Other | group-E (control group; n=14) |
Primary outcome
The gait performance
Time frame: 12-weeks
The gait performance (evaluated using the dynamic gait index). The dynamic gait index is composed of eight items/ tasks. According to the participant's performance; each item is scored on a 4-points ordinal scale from 0 to 3; with "0" indicating the worst achievement (severe impairment) while "3" represents the best score (normal performance).
The functional balance
Time frame: 12-weeks
The functional balance (evaluated using the Berg balance scale). the Berg balance scale constitutes 14 functional tasks, with each task score ranging from "0 to 4" where "0" indicates the lowest level of function; while "4" indicates the independent performance of the task.
1 secondary outcome
Fasting blood glucose level
Time frame: 12-weeks
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 4 Oct 2022.
- 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.
Ashraf Abdelaal principal investigator
Umm Al-Qura 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 Group- A (100% weight-bearing; n=14), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks., Group- B (70% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. and Group- C (50% weight-bearing), (moderate-intensity (50-70% heart rate reserve) aerobic exercise training on the antigravity treadmill, 3 times/week for 12-weeks. in people with Diabetic Peripheral Neuropathy, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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 5 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 4 Oct 2022. 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
The gait performance (time frame: 12-weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2022; AzTrials last refreshed its copy on 7 Nov 2026.