Robotic exoskeleton versus continuous passive motion for rehabilitation after total knee arthroplasty
| ISRCTN | ISRCTN92579733 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN92579733 |
| Sponsor | Sharif University of Technology |
| Funder | Sharif University of Technology |
- Submission date
- 17/06/2026
- Registration date
- 22/06/2026
- Last edited
- 22/06/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This study compares two rehabilitation methods for patients who have undergone total knee replacement surgery.
Who can participate?
Patients aged between 48 and 75 years with a confirmed diagnosis of end-stage knee osteoarthritis treated by unilateral total knee arthroplasty.
What does the study involve?
One group received therapy using a robotic exoskeleton device that assists walking and knee movement. The other group received Continuous Passive Motion (CPM) therapy, where a machine gently moves the knee. Both groups had 45-minute sessions, 5 days a week, for 4 weeks. The study measured pain, walking ability, knee movement, and functional status before and after treatment.
What are the possible benefits and risks of participating?
Benefits and risks not provided at time of registration
Where is the study run from?
School of Science and Engineering, Sharif University of Technology, Iraq.
When is the study starting and how long is it expected to run for?
September 2024 to April 2026.
Who is funding the study?
School of Science and Engineering, Sharif University of Technology, Iraq.
Who is the main contact?
Dr Raed Alalwani, raed.abdalamer@atu.edu.iq
Contact information
Principal investigator, Public, Scientific
School of Science and Engineering, Sharif University of Technology
Kish Island
79417-76655
Iran
| Phone | +9647810360155 |
|---|---|
| raedabdalamer@atu.edu.iq |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Non-randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Effectiveness of robotic exoskeleton versus continuous passive motion on rehabilitation outcomes following total knee arthroplasty: a comparative clinical study |
| Study objectives | To compare the effectiveness of robotic exoskeleton therapy versus Continuous Passive Motion (CPM) on pain, functional mobility, range of motion, and walking ability in patients following total knee arthroplasty. |
| Ethics approval(s) |
Approved 01/01/2024, Al Furat Alawsat Technical University (Almussaib, babelon, 79417-76655, Iraq; +964 7702793694; isam_jettar@yahoo.com), ref: SUT-EC-2024-001 |
| Health condition(s) or problem(s) studied | Knee osteoarthritis; total knee arthroplasty (TKA); post-surgical rehabilitation |
| Intervention | Group 1 (Exoskeleton): Lower-limb robotic exoskeleton therapy, 45 minutes per session, once daily, 5 days per week, for 4 weeks (20 sessions total). Progressive gravity-compensated assistance at the knee joint. Group 2 (CPM): Continuous Passive Motion therapy, 45 minutes per session, once daily, 5 days per week, for 4 weeks (20 sessions total). Initial ROM 0-45 degrees, incrementally increased by 5-10 degrees per session. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Robotic lower-limb exoskeleton device, Continuous Passive Motion (CPM) machine |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 17/04/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 48 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Confirmed diagnosis of end-stage knee osteoarthritis treated by unilateral total knee arthroplasty 2. Age between 48 and 75 years 3. Ability to comprehend and follow verbal instructions 4. Absence of concurrent severe systemic disease |
| Key exclusion criteria | 1. Revision TKA or prior ipsilateral knee surgery within 6 months 2. Severe cognitive impairment affecting participation 3. Neurological conditions affecting lower limb function 4. Contraindications to physical therapy or weight-bearing activities |
| Date of first enrolment | 04/09/2024 |
| Date of final enrolment | 10/08/2025 |
Locations
Countries of recruitment
- Iraq
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | 22/06/2026 | No | No |
Additional files
- 49737_VAS.pdf
- Other files
Editorial Notes
22/06/2026: Study’s existence confirmed by the Republic of Iraq, Ministry of Health.
