Knee Osteoarthritis Clinical Trial
Official title:
Impact of Volunteerism in the Acute Setting: Guiding Rehabilitative Exercises in Patients After Total Knee Replacement (TKR). A Pilot Study
NCT number | NCT04063553 |
Other study ID # | 2018/00638 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 16, 2019 |
Est. completion date | June 15, 2020 |
Rehabilitation, with a particular emphasis on physiotherapy and exercise, is widely promoted and strongly recommended after total knee replacement (TKR). The primary goals of rehabilitation are to improve knee range-of-motion, muscle strength, functional mobility and perceived quality of life. Exercises are usually prescribed and guided by a physiotherapist attending to the patient. The intensity of rehabilitation has an impact on clinical outcome. A study done by Lee et al in 2012 concluded that higher exercise dose translates to better function after TKR, especially in older population and for those with higher pain. Various literatures has also strongly recommended twice a day rehabilitation session for patients after TKR (Cook et al, 2008; Smith et al 2012).
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 15, 2020 |
Est. primary completion date | June 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 55 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Standard unilateral TKR without complications - 55 years or older - Pain less than or equal to 6/10 (i.e or between mild to moderate) - Cognitively intact (able to follow at least 1-step instruction consistently) - Vitals stable (Blood pressure, HR, oxygen saturation) - Able to verbalise understanding and give informed consent - Able to understand Mandarin or English Exclusion Criteria: - Unable to follow instructions consistently due to - Cognitive impairment (Dementia, delirium) - Behavioural issues (Confused, aggressive) - Visually or hearing impaired - Language illiteracy (listening) - Medically unstable such as Hb drop (< 8) , acute desaturation - Reduced exercises tolerance- Unable to tolerate a 20 minutes exercise session - Post-operative complication such as delirium, DVT, cardiac issues. - Excessive bleeding from the wound dressing |
Country | Name | City | State |
---|---|---|---|
Singapore | Tan Tock Seng Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Tan Tock Seng Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Knee flexion and extension range of motion | knee range of motion will be measured using goniometer | through study completion, an average of 5 days | |
Primary | Quadriceps strength | Quads strength will be assessed by using handheld dynamo-meter | through study completion, an average of 5 days | |
Secondary | Pain intensity | pain intensity will be assessed by using VAS scale. VAS scale is a valid scale to assess pain intensity. It is a likert scale with 0-10 with 0 is no pain and 10 is maximum pain, Subject will be asked to give a number based on the pain level that they feel. | through study completion, an average of 5 days | |
Secondary | Timed up and Go test | Functional test to measure the duration needed to complete the task | through study completion, an average of 5 days | |
Secondary | Length of stay | Length of hospital stay to discharge home | through study completion, an average of 5 days | |
Secondary | survey | survey with likert scale 1-5 to investigate patient acceptance and satisfaction level towards volunteer service | through study completion, an average of 5 days | |
Secondary | quiz | quiz with Yes or No to test the knowledge of subjects about post TKR rehab | through study completion, an average of 5 days |
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