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

Sponsor

Umm Al-Qura University (Other)

Overall Status

Completed

CT.gov ID

NCT05565924

Collaborator

(none)

Enrollment

Location

Arms

5.2

Actual Duration (Months)

13.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Diabetic Peripheral Neuropathy	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. 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. 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. 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. Other: Group- E; Control group	N/A

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

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Antigravity Treadmill Training on the Gait Performance and Functional Balance in Patients With Diabetic Peripheral Neuropathy. Randomized Controlled Trial

Actual Study Start Date :

Jan 2, 2022

Actual Primary Completion Date :

Jun 8, 2022

Actual Study Completion Date :

Jun 8, 2022

Arms and Interventions

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").

Outcome Measures

Primary Outcome Measures

The gait performance [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 [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.

Secondary Outcome Measures

Fasting blood glucose level [12-weeks]
Fasting blood glucose level

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).