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Effects of Antigravity Treadmill Training on Gait and Balance in Patients With Diabetic Polyneuropathy

Primary Purpose

Diabetic Polyneuropathy

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Antigravity treadmill training
Conventional exercise program
Sponsored by
Umm Al-Qura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Polyneuropathy

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elderly Saudi men with diabetic polyneuropathy with history of 2 or more falls within the past 12 months
  • Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated hemoglobin (HbA1c) level between 7 and 11 and fasting glucose level ranged 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.
  • They will be selected among old subjects that were able to walk independently with or without assistive device, but with poor balance

Exclusion Criteria:

  • Type 1 Diabetes Mellitus,
  • Patients who had got a score over 19 according to Tinetti scale of balance assessment,
  • Patient with malnutrition (BMI < 21 kg/m2 or with recent weight loss > 5% body weight in the last month or > 10% in six months),
  • Patients with established hypertension (resting systolic blood pressure > 140 mm Hg and diastolic blood pressure > 90 mm Hg,
  • With any severe chronic or uncontrolled comorbid condition 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. wound or scar tissues or are on other complementary treatment,
  • History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems).

Sites / Locations

  • Al Noor Specialized Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Antigravity Treadmill Group

Conventional Exercise Group

Arm Description

This group received antigravity treadmill training 100% weight bearing and conventional exercise program.

This group received the conventional exercise program only.

Outcomes

Primary Outcome Measures

Change from baseline spatial and temporal gait parameters at 3 months
Spatial and temporal gait analysis will be evaluated for every patient at baseline and 3 months post-intervention by using the 3-D motion analysis system.
Change from baseline postural stability at 3 months
Postural stability assessment by using Balance Biodex stability system measuring (antero-posterior, medio-lateral, and overall stability indices.

Secondary Outcome Measures

Change from baseline functional capacity at 3 months
The assessment of functional capacity will be done using Six Minute Walk Test where intensity is moderately higher than daily living activities. Subject will be asked to walk at his own maximal pace from end to end of a 40-meter flat, straight corridor marked every 1 meter with side cones, in order to cover as much ground as possible while maintaining a steady pace without running during the allowed time. No verbal encouragement will be given, and subjects will be informed verbally each 2 minutes of the remaining time. The patients will be allowed to stop, but they can start again, if possible, within the allocated 6 minutes. Distance covered in 6 minutes will be recorded in meter. The longer the distance that will be walked will signify a better performance.

Full Information

First Posted
October 7, 2021
Last Updated
October 19, 2021
Sponsor
Umm Al-Qura University
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1. Study Identification

Unique Protocol Identification Number
NCT05088993
Brief Title
Effects of Antigravity Treadmill Training on Gait and Balance in Patients With Diabetic Polyneuropathy
Official Title
Effects of Antigravity Treadmill Training on Gait and Balance in Patients With Diabetic Polyneuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
June 15, 2021 (Actual)
Study Completion Date
June 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umm Al-Qura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aging can be defined as sequential deterioration that occurs in elderly people including weakness, loss of mobility, decline of physical capabilities, increase susceptibility to disease and many other age-related physiological changes .The beginning of old age in most developed countries is about 60 or 65 years old. Diabetes mellitus (DM) and most commonly type 2 DM is one of the most common chronic non-communicable diseases affecting old people in Saudi Arabia which might be resulted from decline in physical activities. Polyneuropathy (PN) and its serious consequences represent the most common complication in diabetic mellitus which could contribute to an increased gait abnormality and risk of falling.
Detailed Description
Disability and reduction of quality of life are the largest costs of diabetes and its complications. So taking active intervention to reduce the risk of falls, improve gait performance and improve the quality of life in elderly with DPN is very important. Lower extremity aerobic exercise training via treadmill aiming for improving patients' physical activity levels is an important part in the rehabilitation program to enhance balance and walking functions and reducing the fall risk, .Treadmill training using s low-load walking provided by an emerging technology called lower body positive pressure (LBPP) that effectively reduces body weight could be preferable than other methods of unweighting treadmill because the air pressure is applied uniformly over the lower body. This kind of anti-gravity treadmill is ideal in reducing the formation of pain and pressure points that are common with harness-based unweighting systems. Many other advantages are also associated with this unique type of antigravity technology that could give it the superiority than the other types of unweighting treadmills in enhancing walking performance, reducing the risk of fall and improving quality of life in Saudi elderly people with DPN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Polyneuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antigravity Treadmill Group
Arm Type
Experimental
Arm Description
This group received antigravity treadmill training 100% weight bearing and conventional exercise program.
Arm Title
Conventional Exercise Group
Arm Type
Active Comparator
Arm Description
This group received the conventional exercise program only.
Intervention Type
Other
Intervention Name(s)
Antigravity treadmill training
Intervention Description
This group received antigravity treadmill training 100% weight bearing
Intervention Type
Other
Intervention Name(s)
Conventional exercise program
Intervention Description
This group received the conventional exercise program only.
Primary Outcome Measure Information:
Title
Change from baseline spatial and temporal gait parameters at 3 months
Description
Spatial and temporal gait analysis will be evaluated for every patient at baseline and 3 months post-intervention by using the 3-D motion analysis system.
Time Frame
Baseline and 3 months post-intervention
Title
Change from baseline postural stability at 3 months
Description
Postural stability assessment by using Balance Biodex stability system measuring (antero-posterior, medio-lateral, and overall stability indices.
Time Frame
Baseline and 3 months post-intervention
Secondary Outcome Measure Information:
Title
Change from baseline functional capacity at 3 months
Description
The assessment of functional capacity will be done using Six Minute Walk Test where intensity is moderately higher than daily living activities. Subject will be asked to walk at his own maximal pace from end to end of a 40-meter flat, straight corridor marked every 1 meter with side cones, in order to cover as much ground as possible while maintaining a steady pace without running during the allowed time. No verbal encouragement will be given, and subjects will be informed verbally each 2 minutes of the remaining time. The patients will be allowed to stop, but they can start again, if possible, within the allocated 6 minutes. Distance covered in 6 minutes will be recorded in meter. The longer the distance that will be walked will signify a better performance.
Time Frame
Baseline and 3 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elderly Saudi men with diabetic polyneuropathy with history of 2 or more falls within the past 12 months Diagnosed as having uncontrolled Type 2 Diabetes Mellitus, with glycosylated hemoglobin (HbA1c) level between 7 and 11 and fasting glucose level ranged 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. They will be selected among old subjects that were able to walk independently with or without assistive device, but with poor balance Exclusion Criteria: Type 1 Diabetes Mellitus, Patients who had got a score over 19 according to Tinetti scale of balance assessment, Patient with malnutrition (BMI < 21 kg/m2 or with recent weight loss > 5% body weight in the last month or > 10% in six months), Patients with established hypertension (resting systolic blood pressure > 140 mm Hg and diastolic blood pressure > 90 mm Hg, With any severe chronic or uncontrolled comorbid condition 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. wound or scar tissues or are on other complementary treatment, History of serious cerebrovascular or cardiovascular diseases, and severe debilitating musculoskeletal problems).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shamekh M Elshamy, Ph.D.
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Al Noor Specialized Hospital
City
Mecca
ZIP/Postal Code
715
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Antigravity Treadmill Training on Gait and Balance in Patients With Diabetic Polyneuropathy

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