Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
traumatic brain injury (TBI) is a major public health concern worldwide. Patients with moderate-severe TBI have high rates of disability at the acute phase and frequently require protracted rehabilitation with prolonged periods of recovery. Recently, it has been found that the use of progressive early mobilization (EM) protocols for critical trauma patients may minimize the functional declines during intensive care unit (ICU) stays. However, prior early mobilization studies have found that the survivors of moderate-severe TBI often experience a greater incidence of neurological injuries with other organ injury than other critical care patients. No randomized controlled trials thus far have utilized measure the influence or effect of early progressive EM protocols on the functional recovery of moderate-severe TBI patients.
Objective: The goals of this proposed research study are (1) to investigate the feasibility of using a structured progressive EM protocol for patients with moderate-severe TBI in a trauma ICU and (2) The goal is to investigate and compare the intervention effects of a progressive EM protocol (aimed at bringing patients at least to the mobility level-3 of sitting on the edge of bed) in an ICU on short-term and long-term functional abilities in patients with moderate-severe TBI.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| early mobilization (ER) group | Experimental | Participants in the EM group will undergo the progressive early mobilization protocol in the trauma ICU in a manner consistent with the our hospital practice guidelines indicated by the Modified ICU Mobility Scale for progressive mobilization during the ICU stay. EM will be started with in-bed exercises and, if no medical contraindications are present, progressed from sitting in bed with the head tilted >60° to sitting on the edge of the bed to standing (including pre-gait exercises to improve postural stability, static and dynamic balance, and marching on the spot) and, finally, to walking. |
|
| standard early rehabilitation (SER) group | Active Comparator | Patients in the SER group (Progressive upright positioning protocol) will receive standard physiotherapy including passive range of motion exercises, active exercises, bed mobility, and respiratory therapy during their ICU stays. In the SER group, out-of-bed mobilization (>=Level III in the Modified Trauma ICU Mobility Scale) will be started as soon as possible after ICU discharge but at least Level III (sitting on the edge of bed) above 7 days of onset. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early progressive mobilization | Behavioral | The goal will be to achieve a mobilization level of at least Level III (sitting on the edge of bed) during the ICU stay (within 7 days). |
| Measure | Description | Time Frame |
|---|---|---|
| The total score-change of the Perme ICU Mobility Score | The Perme ICU Mobility Score ranges from 0 to 32 points and is obtained by summing the score of 15 items, each one scored from 2 to 3 points. This score reflects the patient's mobility status in specific circumstances. | at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset |
| Measure | Description | Time Frame |
|---|---|---|
| The total score-change of the motor domain of the Functional Independence Measure (FIM-motor) | the FIM-motor consist of self-care tasks (eating, grooming, bathing, upper-body dressing, lower-body dressing, and using the toilet), sphincter control (bladder and bowel management), transfers (from bed or a chair to the toilet, bath, or shower), and locomotion ability (walking or wheelchair mobility, and stair climbing) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hung-Jui Chuang, Dr | Department of Physical Medicine and Rehabilitation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 110 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38778416 | Derived | Yen HC, Chuang HJ, Hsiao WL, Tsai YC, Hsu PM, Chen WS, Han YY. Assessing the impact of early progressive mobilization on moderate-to-severe traumatic brain injury: a randomized controlled trial. Crit Care. 2024 May 22;28(1):172. doi: 10.1186/s13054-024-04940-0. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| at baseline; at the time of ICU discharge; the time of hospital discharge (an average of 30 days); three-month after onset |
| the achievement level of Modified Trauma ICU Mobility Scale | the achievement of Modified Trauma ICU Mobility Scale, Level 0-10 | at baseline; at the time of ICU discharge; the time of hospital discharge |
| the days of achievement of the walking motor milestone | walking on a level surface for ≥50 meters with or without an assistive device | up to 3 months |
| the values tested by in body s10 about lean body mass parameters | including phase angle, skeletal muscle mass, body fat mass, total body water etc. | at baseline; at the time of ICU discharge; the time of hospital discharge/ an average of 30 days; |
| the length of stay in the ICU | the length of stay in the ICU | up to 3 months |
| the hospital length of stay | the hospital length of stay | up to 3 months |
| the days of ventilator used | the days of ventilator used | up to 3 months |
| the discharge disposition after hospital discharge | where a patient is being discharged - i.e. home, home with home care, skilled nursing facility, or rehab center. | up to 3 months |
| D001523 |
| Mental Disorders |