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

Sponsor
Imam Abdulrahman Bin Faisal University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05846633
Collaborator
(none)
32
Enrollment
2
Arms
12.1
Anticipated Duration (Months)

Study Details

Study Description

Brief 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. 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: Thirty-two elderly participants will be equally and randomly assigned to Group-I: Sixteen participants will be trained on C-Mill treadmill for 50 minutes per session /2 session /week for six successive weeks. Group-II: Sixteen 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%.

Condition or Disease Intervention/Treatment Phase
  • Device: C mell treadmill
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
the participants will be randomly assigned to 2 groups for intervention, none of them knows which arm will be for intervention
Primary Purpose:
Treatment
Official Title:
Effectiveness of C-Mill Treadmill Training Versus Conventional Treadmill on Balance and Psychological Status in Elderly Population. A Randomized Clinical Trial.
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
May 2, 2024
Anticipated Study Completion Date :
May 2, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

  2. Berg Balance Scale [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

  3. The Timed Up and Go Test (TUG) [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.

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

  5. The Beck Depression Inventory (BDI) [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. Geriatric Depression Scale - 15 (short form) (GDS-15) [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

  7. Depression in Old Age Scale (DIA-S [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.

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Imam Abdulrahman Bin Faisal University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ayman Mohammed Zafer, PhD Candidate in neurological rehabilitation Sciences, Imam Abdulrahman Bin Faisal University
ClinicalTrials.gov Identifier:
NCT05846633
Other Study ID Numbers:
  • C mell
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ayman Mohammed Zafer, PhD Candidate in neurological rehabilitation Sciences, Imam Abdulrahman Bin Faisal University
elderly
fall risk
gait
balance
virtual reality
treadmill

Study Results

No Results Posted as of May 6, 2023