Alter-G Training on Gait and Balance in Diabetic Neuropathy Patients

September 29, 2022 updated by: Ashraf Abdelaal, Umm Al-Qura University

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

58 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group-A
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").
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.
Moderate-intensity aerobic exercise training on the antigravity treadmill (100% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).
Other Names:
  • Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Experimental: Group-B
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").
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.
Moderate-intensity aerobic exercise training on the antigravity treadmill (70% weight-bearing) plus medications plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)
Other Names:
  • Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Experimental: Group-C
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").
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.
Moderate-intensity aerobic exercise training on the antigravity treadmill (50% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)
Other Names:
  • Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Experimental: group-D (30% weight-bearing; n=13)
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").
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.
Moderate-intensity aerobic exercise training on the antigravity treadmill (30% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).
Other Names:
  • Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").
Sham Comparator: group-E (control group; n=14)
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").
Other: Group- E; Control group
Control: No aerobic exercise training on the antigravity treadmill, but only medications (Biguanide alone or "Sulfonylureas plus Biguanide combination) throughout the study.
Other Names:
  • Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12-weeks
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.
12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting blood glucose level
Time Frame: 12-weeks
Fasting blood glucose level
12-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umm Al-Qura University

Investigators

  • Principal Investigator: Ashraf Abdelaal, Umm Al-Qura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2022

Primary Completion (Actual)

June 8, 2022

Study Completion (Actual)

June 8, 2022

Study Registration Dates

First Submitted

June 10, 2022

First Submitted That Met QC Criteria

September 29, 2022

First Posted (Actual)

October 4, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

September 29, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-MED1319-10_IR1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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