Effects of Lower Limb Positive Pressure on the Balance of Community-dwelling Older Adults

Fall Clinical Trial

Official title:

Effects of Lower Limb Positive Pressure on the Balance of Community-dwelling Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636645
• Other study ID #: Riphah/RCRS/REC/0011961
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: August 2021
• Source: Riphah International University
• Contact: Waqar Ahmed Awan
• Phone: 03324390125
• Email: waqar.ahmed[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the onset of the sixth decade in life, degenerative processes affect the neuromuscular system in terms of losses in muscle strength (dynapenia) and muscle mass (sarcopenia). Neural (e.g., numerical loss of alpha motoneurons) and morphological factors. Borde et al. 123 number and size of particularly type-II muscle fibers), as well as their interaction, are responsible for age-related declines in muscle strength and mass. There is evidence that muscular weakness is highly associated with impaired mobility and an increased risk for falls. Moreover, lower extremity muscle weakness was identified as the dominant intrinsic fall-risk factor with a five-fold increase in the risk of falling. An anti-gravity treadmill allows users to walk or run in a reduced body weight environment. The user walks or runs on a treadmill belt surrounded by an enclosed, air-filled chamber. When air pressure increases, an upward force offloads the weight of the runner and decreases the percentage of body weight (BW%) experienced upon foot impact. So, a research question was developed in our mind after the literature review. Is there any effect of AGT training on fall risk of older adults?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

1. Community-dwelling adults aged 55 years and above.

2. Berg balance score should be from 46 to 54.

3. Able to follow instructions in Urdu.

4. No neurological conditions, and no musculoskeletal injuries within the past year.

5. Both male and female.

Exclusion Criteria:

1. Pain with ambulation or dizziness when standing or walking.

2. Contraindications to treadmill walking and LBPP such as cardiovascular conditions.

3. Severe osteoporosis, fractures, when loading of the abdominal region, hip or pelvis is contraindicated (such as groin infections, skin graft in the groin region, gastrointestinal tubes, colostomy, compromised skin integrity), orthopedic conditions in the past year or neurological conditions.

Related Conditions & MeSH terms

• Fall
• Old Age

Intervention

Other:
• Normal treadmill
Participants will exercise for 25 minutes under low-load walking conditions three times a week for 8 consecutive weeks on the AGT treadmill at a set speed of 3.1 mph at 0-degree incline. For each session, 20% support will be given to participants.
• Anti-gravity treadmill with lower limb positive pressure
Participants will be exercised for 25 minutes under normal-load walking conditions three times a week for 8 consecutive weeks on the AGT treadmill at a set speed of 3.1 mph at 0-degree incline. Participants will be blinded to the study groups.
• Anti-gravity treadmill with without lower limb positive pressure
Participants will be exercised for 25 minutes three times a week for 8 consecutive weeks on the normal treadmill at a set speed of 3.1 mph at a 0-degree incline. Participants will be blinded to the study groups.

Locations

Country	Name	City	State
Pakistan	Fauji Foundation Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed up and go test (TUG)	Test is also commonly used to evaluate fall risk.A faster time for completion of required task indicates a better ability to perform functional activities. The person sits up from the chair after instruction and walks at his normal pace for 3 meters, takes a turn and sits down after walking back towards the chair. The total duration required for this activity is measured using a stop watch.	12 week
Primary	Berg balance scale	Evaluation of functional balance was done using BBS which is valid and reliable tool for dynamic and static balance assessment. It consists of 14 Items and balance is assessed using an ordinal scale comprising 5 points that ranges from 0 to 4. High scores are indicative of superior balance where as low scores are suggestive of increased fall risk and poor balance.	12 week
Primary	Functional reach test	This test is used to assess stability level of patient. The assessment is carried out by calculating the maximum distance a person is able to reach forward in a fixed standing position. The assessment is carried out by calculating the maximum distance a person is able to reach forward in a fixed standing position. Lower distance of functional reach test indicated higher risk of fall and deteriorated balance and vice versa.	12 week
Primary	Fall risk score	FRS provide an objective assessment of static and dynamic balance and was assessed using dynamic posturo graphy system. High scores of FRS indicated higher risk of fall and deteriorated balance and vice versa.	12 week
Primary	Balance App	There are six different tasks that subject have perform with system, like, normal walking up to 6 meters, walking with head movement, standing with eyes open and close and standing on a compromised surface with eyes open and close. High scores indicated higher risk of fall and deteriorated balance and vice versa.	12 week
Secondary	Force Plate	Force plates is portable, non-invasive and quantitative instrument used to measure the ground reaction forces, variation in center of gravity and forces impact on foot. Postural sways will be calculated from force plate data. Randomness in data show increase risk of fall and poor balance.	12 week.