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

NCT05565924 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2022-10-04

No results posted yet for this study

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

Interventions

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

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

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

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

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.

Sponsors & Collaborators

  • Umm Al-Qura University

    lead OTHER

Principal Investigators

  • Ashraf Abdelaal · Umm Al-Qura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-02
Primary Completion
2022-06-08
Completion
2022-06-08

Countries

  • Saudi Arabia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05565924 on ClinicalTrials.gov