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

NCT ID: NCT05846633

Last Updated: 2023-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-05-02

Brief Summary

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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%.

Detailed Description

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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

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Elderly Geriatric

Keywords

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elderly fall risk gait balance virtual reality treadmill

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
the participants will be randomly assigned to 2 groups for intervention, none of them knows which arm will be for intervention

Study Groups

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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.

Group Type EXPERIMENTAL

C mell treadmill

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

C mell treadmill

Intervention Type DEVICE

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

Interventions

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C mell treadmill

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

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

65 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imam Abdulrahman Bin Faisal University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Mohammed Zafer

PhD Candidate in neurological rehabilitation Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

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Other Identifiers

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IRB-PGS-2023-03-253

Identifier Type: -

Identifier Source: org_study_id