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ElderlyNCT05846633

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

A study testing C mell treadmill in people with Elderly and Geriatric, run by Imam Abdulrahman Bin Faisal University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 65 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Elderly, Geriatric
What is being tested?
C mell treadmill
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
No sites listed yet
Study dates
15 Dec 2023to 2 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 11Show fewer
  • 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).

About this study

Official title: 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%.

Read the 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

Conditions
Elderly, Geriatric
Being tested
C mell treadmill
Keywords
elderly, fall risk, gait, balance, virtual reality, treadmill

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • C mell treadmillDevice

    C Mell treadmill provides Virtual Reality environment for rehabilitation with obstacles and motivational assistance

Study groups in NCT05846633
Study groupRoleWhat they receive
VR treadmillExperimentalThe 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.
Receives: Device: C mell treadmill
Conventional groupActive comparatorLike 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.
Receives: Device: C mell treadmill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Biodex Balance System (BBS; Biodex Inc., Shirley, NY)

    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.

    Measured: 6 Weeks

  2. Berg Balance Scale

    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

    Measured: 6 weeks

  3. The Timed Up and Go Test (TUG)

    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.

    Measured: 6 weeks

  4. The six-minute walk test (6MWT)

    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

    Measured: 6 Weeks

  5. The Beck Depression Inventory (BDI)

    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

    Measured: 6 Weeks

  6. Geriatric Depression Scale - 15 (short form) (GDS-15)

    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

    Measured: 6 Weeks

  7. Depression in Old Age Scale (DIA-S

    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.

    Measured: 6 Weeks

  8. Depression Anxiety Stress Scale-21 (DASS-21) Arabic version

    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.

    Measured: 6 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2023
  2. Study start15 Dec 2023 (estimated)
  3. Primary completion2 May 2024 (estimated)
  4. Study completion2 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05846633
Sponsor's protocol ID
IRB-PGS-2023-03-253
Status last verified
Dec 2023
First submitted
27 Apr 2023
Last updated
15 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alabdullgader A, Rabbani U. Prevalence and Risk Factors of Falls Among the Elderly in Unaizah City, Saudi Arabia. Sultan Qaboos Univ Med J. 2021 Feb;21(1):e86-e93. doi: 10.18295/squmj.2021.21.01.012. Epub 2021 Mar 15.

    PubMed 33777428

  • Alghnam S, Alsayyari AS, Towhari JA, Alsayer RM, Almohaimeed MY, Aldebasi MH, Albabtin IT. Epidemiological characteristics of fall injuries and their related outcome in Riyadh, Saudi Arabia: A descriptive study from a Level-I trauma center. J Family Community Med. 2020 May-Aug;27(2):114-119. doi: 10.4103/jfcm.JFCM_245_19. Epub 2020 Jun 3.

    PubMed 32831557

  • Ali AM, Ahmed A, Sharaf A, Kawakami N, Abdeldayem SM, Green J. The Arabic Version of The Depression Anxiety Stress Scale-21: Cumulative scaling and discriminant-validation testing. Asian J Psychiatr. 2017 Dec;30:56-58. doi: 10.1016/j.ajp.2017.07.018. Epub 2017 Jul 18.

    PubMed 28755630

  • Almegbel FY, Alotaibi IM, Alhusain FA, Masuadi EM, Al Sulami SL, Aloushan AF, Almuqbil BI. Period prevalence, risk factors and consequent injuries of falling among the Saudi elderly living in Riyadh, Saudi Arabia: a cross-sectional study. BMJ Open. 2018 Jan 10;8(1):e019063. doi: 10.1136/bmjopen-2017-019063.

    PubMed 29326189

  • Alshammari SA, Alhassan AM, Aldawsari MA, Bazuhair FO, Alotaibi FK, Aldakhil AA, Abdulfattah FW. Falls among elderly and its relation with their health problems and surrounding environmental factors in Riyadh. J Family Community Med. 2018 Jan-Apr;25(1):29-34. doi: 10.4103/jfcm.JFCM_48_17.

    PubMed 29386959

  • Ashworth NL, Chad KE, Harrison EL, Reeder BA, Marshall SC. Home versus center based physical activity programs in older adults. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD004017. doi: 10.1002/14651858.CD004017.pub2.

    PubMed 15674925

  • Beck, A. T., Steer, R. A., & Carbin, M. G. (1988). Psychometric properties of the Beck Depression Inventory: Twenty-five years of evaluation. Clinical psychology review, 8(1), 77-100.

  • Berg KO, Wood-Dauphinee SL, Williams JI, Maki B. Measuring balance in the elderly: validation of an instrument. Can J Public Health. 1992 Jul-Aug;83 Suppl 2:S7-11.

    PubMed 1468055

  • Berger-Vachon, C. (2006). Virtual reality and disability. Technology and Disability, 18(4), 163-165.

  • Berry, B. D. (2013). Effects of upper body resistance while treadmill walking in older adults (Doctoral dissertation, Wichita State University).

  • Blazer DG. Depression in late life: review and commentary. J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):249-65. doi: 10.1093/gerona/58.3.m249.

    PubMed 12634292

  • Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.

    PubMed 7183759

  • Britton A, Shipley M, Singh-Manoux A, Marmot MG. Successful aging: the contribution of early-life and midlife risk factors. J Am Geriatr Soc. 2008 Jun;56(6):1098-105. doi: 10.1111/j.1532-5415.2008.01740.x. Epub 2008 May 12.

    PubMed 18482302

  • Burns ER, Stevens JA, Lee R. The direct costs of fatal and non-fatal falls among older adults - United States. J Safety Res. 2016 Sep;58:99-103. doi: 10.1016/j.jsr.2016.05.001. Epub 2016 May 28.

    PubMed 27620939

  • Cabeza, R., Nyberg, L., & Park, D. C. (Eds.). (2016). Cognitive neuroscience of aging: Linking cognitive and cerebral aging. Oxford University Press.

Questions about this trial

What is this clinical trial studying?

A study testing C mell treadmill in people with Elderly and Geriatric, run by Imam Abdulrahman Bin Faisal University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biodex Balance System (BBS; Biodex Inc., Shirley, NY) (time frame: 6 Weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05846633, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2023.

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