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

Imam Abdulrahman Bin Faisal University

Status: Not yet enrolling

Conditions: Geriatric; Elderly

Treatments: Device: C mell treadmill

Study type: Interventional

Funder types: Other

Identifiers

NCT05846633

IRB-PGS-2023-03-253

Details and patient eligibility

About

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%.

Full 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

Enrollment: 58 estimated patients

Sex: All

Ages: 65 to 75 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

58 participants in 2 patient groups

VR treadmill

Experimental group

Description:

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.

Treatment:

Device: C mell treadmill

Conventional group

Active Comparator group

Description:

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.

Treatment:

Device: C mell treadmill