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

NCT05565924 | Completed DMC

• 1 other identifier: 13-MED1319-10_IR1
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic neuropathy; Gait; Balance

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  12-weeks

Secondary Outcomes (1)

• Fasting blood glucose level

  12-weeks

Study Arms (5)

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").

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").

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").

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").

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").

Other: Group- E; Control group

Interventions

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

Moderate-intensity aerobic exercise training on the antigravity treadmill (70% weight-bearing) plus medications plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)

Also known as: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

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. OTHER

Moderate-intensity aerobic exercise training on the antigravity treadmill (50% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination)

Also known as: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

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. OTHER

Moderate-intensity aerobic exercise training on the antigravity treadmill (30% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).

Also known as: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

group-D (30% weight-bearing; n=13)

Group- E; Control group OTHER

Control: No aerobic exercise training on the antigravity treadmill, but only medications (Biguanide alone or "Sulfonylureas plus Biguanide combination) throughout the study.

Also known as: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

group-E (control group; n=14)

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

Moderate-intensity aerobic exercise training on the antigravity treadmill (100% weight-bearing) plus medications (Biguanide alone or "Sulfonylureas plus Biguanide combination).

Also known as: Oral drug therapy (Biguanide alone or "Sulfonylureas plus Biguanide combination").

Group-A

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Weight-Bearing; Drug Therapy; Biguanides; Sulfonylurea Compounds; Control Groups

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena; Therapeutics; Guanidines; Amidines; Organic Chemicals; Urea; Amides; Sulfones; Sulfur Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Ashraf Abdelaal

  Umm Al-Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: October 4, 2022
• Study Start: January 2, 2022
• Primary Completion: June 8, 2022
• Study Completion: June 8, 2022
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)