Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly

December 9, 2023 updated by: Ayman Mohammed Zafer, Imam Abdulrahman Bin Faisal University

Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly Population: A Randomized Clinical Trial

Background: Aging is characterized by reduced cognitive and physical functions; consequently, balance, falling and different activities of daily living get exaggerated reductions. Psychological status and falling are related bidirectionally. Depression is a common mental or mood disorder affecting more than 264 million people worldwide. It is a recurrent state of unhappiness and loss of interest. It is not simple as fluctuating mood because of short emotional response. To prevent falling, functional mobility and impairment of balance should be addressed. Many studies have shown that treadmill training is effective in improving the elderly person's ability to walk. The C-Mill treadmill afford a safe virtual reality environment and challenging obstacles and balance games, which increase of walking and improve everyday life performance. Aims: This study aims are to investigate the clinical effectiveness of virtual reality treadmill training on psychological status and balance in elderly population in addition to compare the significant differences between them. Materials & Methods: Fifty-Eight elderly participants will be equally and randomly assigned to Group-I: Twenty-Nine participants will be trained on C-Mill treadmill for 50 minutes per session /2 session /week for six successive weeks. Group-II: Twenty-Nine participants will be trained on conventional treadmill for 50 minutes per session /2 session /week for six successive weeks. Psychological status and Depression will be evaluated by using the Depression Anxiety Stress Scale-2, Geriatric Depression Scale and the Beck Depression Inventory while the balance will be evaluated by using Berge balance scale and timed up and go test, whereas the functional capacity will be measured by using 6 MWT. Statistical analysis: The data will be statistically analysis by using (SPSS version 25). The Shapiro walk test will be used to examine the normality of data distribution. Independent t- test will be used to determine significant differences between two groups (between groups) and paired t- test to determine significant differences before and after intervention in both groups. Significance level at <0.05 and confidence interval CI with 95%.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Fifty-Eight elderly participants will be equally and randomly assigned to Group-I: Twenty-Nine participants will be trained on C-Mill treadmill for 50 minutes per session /2 session /week for six successive weeks. Group-II: Twenty-Nine participants will be trained on conventional treadmill for 50 minutes per session /2 session /week for six successive weeks. Psychological status and Depression will be evaluated by using the Depression Anxiety Stress Scale-2, Geriatric Depression Scale and the Beck Depression Inventory while the balance will be evaluated by using Berge balance scale and timed up and go test, whereas the functional capacity will be measured by using 6 MWT

Study Type

Interventional

Enrollment (Estimated)

58

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • elderly male & female (60-75 years old) subjects will participate in this study. Based on a confirmed written medical report and signed by their physicians. They should be with controlled and stable medical condition, neither Vit-D deficient nor thyroid affected. Participants should have an acceptable level of cognitive function (score 25 or more on Mini-Mental State Examination, score 40 or less on Berg Balance Scale (BBSand score more than 5 on Geriatric Depression Scale (GDS).

All participants should not receive other training to improve their balance and gait other than the protocol of this study.

Exclusion Criteria:

Participants will be excluded if they have one of the following conditions:

  • Medically unstable
  • Fxed lower limb bony deformities
  • Muscle paralysis,
  • Cerebellar impairment,
  • Visual problems,
  • Vestibular problems,
  • Cognitive reduction, any condition may lead to problematic exercises
  • Using vertigo or anti-seizures medications,
  • Score more than 40 on Berg Balance Scale (BBS)
  • Score less than 5 on Geriatric Depression Scale (GDS).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VR treadmill

The intervention of this study will be C-Mill virtual reality treadmill (Motekforce Link, Amsterdam/Culemborg, The Netherlands).

Sixteen participants will be included in the c-mill treadmill program for 50 minutes per session / two sessions per week, over six successive weeks (a total of 12 sessions).

Every participant will be trained for (50 minutes) as follows: warming up by walking on the treadmill with a comfortable walking speed upon individual's capability for 5 minutes. The speed should be determined for each one. Then participants continue training on the treadmill for 20 minutes. Visually guided stepping exercises will be applied. Participants should get a (5-min break) and then resume training on the treadmill for 25 minutes. Obstacle avoidance exercises and Walking area practice will be applied.
Device: C mell treadmill
C Mell treadmill provides Virtual Reality environment for rehabilitation with obstacles and motivational assistance
Active Comparator: Conventional group
Like group I, each participant will be trained on a conventional treadmill for (50 minutes) as follows: warming up by walking on the treadmill belt with a comfortable walking speed suitable for each participant for 5 minutes. The speed should be determined Then participants continue training on the treadmill for 20 minutes; no VR will be used or applied. Participants should get a 5-min break and then resume training on the treadmill again for 25 minutes.
Device: C mell treadmill
C Mell treadmill provides Virtual Reality environment for rehabilitation with obstacles and motivational assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biodex Balance System (BBS; Biodex Inc., Shirley, NY)
Time Frame: 6 Weeks
It will be utilized as a reliable and valid device for measuring balance stability during standing in both static and dynamic situations (Cachupe et al.,2001 and Chen et al., 2014). Two balance tests will be performed: Limit of Stability (LOS) and Fall risk test. Both tests challenge the ability of participants to control and maintain balance by maintaining their center of gravity within their base of support. The Biodex system has both a static and dynamic mode with 12 levels of platform tilt (greatest stability level = level 12; least stability level = level 1). The static mode and dynamic level (11) of platform tilt will be e selected in this study to perform PST and LOS tests.
6 Weeks
Berg Balance Scale
Time Frame: 6 weeks
a 14-item list; each will be scored ranging from (0-4); 0 is the lowest and 4 is the highest function (0 -20 = high fall risk, 21-40 = medium fall risk and 41-56 = low fall risk). This tool is valid and reliable
6 weeks
The Timed Up and Go Test (TUG)
Time Frame: 6 weeks
It will be used to assess the following parameters in older adults: fall risk, walking ability, balance, and mobility. Participants while wearing regular footwear will start from sitting position by standing up upon therapist's command; walk forward for 3 meters, turn around, walk back to the chair and sit down when timing should stop. Any assistive devices should be noted. It is a reliable, valid, and sensitive test that is a specific measure of the probability for falls among elderly.
6 weeks
The six-minute walk test (6MWT)
Time Frame: 6 Weeks
It will assess the distance that the participant's walking capacity for a total of six minutes on a hard, uneven surface. The 6MWT was originally developed in frail elderly patients aged 60-90 years referred to a geriatric hospital. It has been used to determine exercise tolerance changes following interventions for healthy older adults
6 Weeks
The Beck Depression Inventory (BDI)
Time Frame: 6 Weeks
It is a 21-items and self-report form used to assess the presence and severity of symptoms of depression in adults (13-80 years old). Questions should be answered upon participant's feeling during last 2 weeks. The BDI takes approximately 10 minutes to complete. The higher the Beck score the higher the feelings of depression; (1-10) These ups and downs are considered normal, (11-16) mild mood disturbance (17-20) borderline clinical depression (21-30) moderate depression (31-40) severe depression above 40 reflects extreme depression. This tool is reliable and has been validated and standardized on geriatric population with relatively less somatic-related items
6 Weeks
Geriatric Depression Scale - 15 (short form) (GDS-15)
Time Frame: 6 Weeks
It is a 15-items, and self-report form. All are YES/NO question, each is worth one point and should be answered based on participant's feeling over last week. 10 items indicate presence of depression if answered positively, while the other 5 indicate depression if answered negatively. This form can be completed in approximately 5 to 7 minutes. This tool has been validated and has a high correlation with depressive symptoms and differentiates between depressed from non-depressed patients. It is valid and reliable scale in geriatrics with a cut-off score of 6 on GDS-15 has 94% sensitivity and 85% specificity in community dwelling older adults, while a cut-off score of 5 has 72% sensitivity and 78% specificity in home care patients
6 Weeks
Depression in Old Age Scale (DIA-S
Time Frame: 6 Weeks
is a self-report instrument consists of ten (Yes/No) short statements that focus on emotional, motivational, and cognitive symptoms of . It has a higher specificity and internal consistency (Heidenblut & Zank, 2010). This tool is recommended for research and clinical practice (Heidenblut & Zank, 2020). Score ranges from (0-10); where (0 = no depressive symptoms) and (10 = maximal depressive symptoms); where 4 is an indicative for a depressive disorder.
6 Weeks
Depression Anxiety Stress Scale-21 (DASS-21) Arabic version
Time Frame: 6 Weeks
is a self-report instrument that consists of three domains; each domain has seven items. Using a four-point Likert scale (0-3), it assesses the negative emotional symptoms. 3 indicates higher severity of negative symptoms. The three domains are: Depression scale, Anxiety scale, and Stress scale. This tool is valid and has excellent reliability.
6 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imam Abdulrahman Bin Faisal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2023

Primary Completion (Estimated)

May 2, 2024

Study Completion (Estimated)

May 2, 2024

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 6, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB-PGS-2023-03-253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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