Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04951414
• Collaborator: (none)
• Enrollment: 600
• Locations: 2
• Anticipated Duration (Months): 18
• Patients Per Site: 300
• Patients Per Site Per Month: 16.7

Study Details

Study Description

Brief Summary

To solve the existing Knee osteoarthritis;KOA) clinical norms and guidelines have low operability, Disconnection between treatment plan and specific evaluation results, difficulty in achieving individualized intervention and other problems, on the one hand, we need to develop Chinese expert consensus or clinical path based on evidence-based medicine to adapt to China's national conditions, on the other hand, is more important in The KOA clinical process introduces a set of tools to translate evidence-based medicine evidence into specific, actionable treatments, Thus, a more flexible, more comprehensive and three-dimensional, adaptable, targeted, more conducive to the promotion of the individual integration KOA rehabilitation intervention program.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Diagnostic Test: ICF core set

Study Design

• Study Type: Observational
• Anticipated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study on the Rehabilitation Treatment of Knee Osteoarthritis Based on ICF
• Anticipated Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
ICF	Diagnostic Test: ICF core set; KOA rehabilitation regimen based on the complete core combination of ICF was accepted
Control

Outcome Measures

Primary Outcome Measures

1. treatment compliance [1month]

   treatment compliance of rehabilitation treatment

2. treatment compliance [3month]

   treatment compliance of rehabilitation treatment

3. treatment compliance [6month]

   treatment compliance of rehabilitation treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Neither knee had undergone knee replacement, and no knee replacement had been performed in recent half a year planning to have a knee replacement; Volunteered to participate in the study and signed the informed consent.

Exclusion Criteria:

• People with consciousness disorder, cognitive disorder, severe mental illness, unable to accurately express their own will, or unable to cooperate with the completion of various assessments and treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Capital clinical characteristic applied research and achievement promotion	Beijing	Beijing	China	100191
2	Huarunwugang general hospital	Wuhan	Hubei	China

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

• Study Director: YUANMINGFEI ZHANG, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04951414
• Other Study ID Numbers: D181100000318004
• First Posted: Jul 6, 2021
• Last Update Posted: Jul 6, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Jul 6, 2021