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Calisthenic and Neuromuscular Training in Patients With Knee OA.

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Calisthenic Training
Neuromuscular Training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Calisthenic training, Neuromuscular training, Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects with chronic OA (symptoms for more than 3 months).
  2. Subjects willing to participate and take treatment.
  3. Grade of 2 to 3 as per Kellegren and Lawrence radiographic classification.

Exclusion Criteria:

  1. Subjects having any systemic joint pathologies, inflammatory joint disease (e.g.

    Rheumatoid arthritis, gouty arthritis, psoriatic arthritis).

  2. Subjects who had any neurological deficit (paresthesia, sensory loss, radiculopathy, myelopathy any mental illness (Dementia, Alzheimer's, Parkinson disease etc.) that can affect orientation and concentration.
  3. Subjects on medication like antidepressants, corticosteroid, and anti-inflammatory medications.
  4. Peripheral vascular diseases.
  5. Any history of surgery related to lower extremity.
  6. Subjects having metal implants in the lower limb

Sites / Locations

  • Riphah International University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Calisthenic Training

Neuromuscular Training Group

Arm Description

Calisthenic Training Group

Neuromuscular Training Group

Outcomes

Primary Outcome Measures

WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Changes are measured from baseline. This test is used to measure physical function. The maximum score is 96 Higher the score the worst is pain, stiffness and physical function.
NPRS(Numeric pain rating scale)
Changes are measured from baseline. The test is used to measure pain. It score ranges from 0 to 10 with 0 indicating no pain and 10 is for pain as severe as possible
Short Physical Performance Battery
Changes are measured from baseline. The test is used to measure balance ,lower extremity strength and functional capacity with maximum score of 12. Score less than 10 indicates disability.
Mini BES-Test
Changes are measured from baseline. It is 36 items scales that evaluates Balance with total score of 28

Secondary Outcome Measures

Full Information

First Posted
November 18, 2021
Last Updated
April 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05173649
Brief Title
Calisthenic and Neuromuscular Training in Patients With Knee OA.
Official Title
Effect of Calisthenics and Neuromuscular Training in Patients With Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.
Detailed Description
OsteoArthristis (OA) is the most frequent form of arthritis and a leading cause of pain and disability worldwide. OA can affect any synovial joint, although the hip, knee, hand, foot and spine are the most commonly affected sites. The knee is the most commonly affected joint and knee OA (KOA) represents the leading joint disorder in the world. At present, there is no preventive or curative drug treatment available for KOA. Physical therapy plays a significant role in treating patients with knee OA. Rehabilitation enables the patient to cope with their daily task independently and mainly focus on self-help and patient-driven treatments rather than on passive therapies delivered by clinicians. A systemic review was conducted on Comparative Effect of Calisthenics and Proprioceptive Exercises on Pain, Proprioception, Balance and Function in Chronic Osteoarthritis of Knee. According to this study Light intensity Calisthenics exercises are effective and can be recommended as an adjunct to conventional physiotherapy for the patients with Osteoarthritis knee. Another research was conducted on Efficacy of Neuromuscular Training on Pain, Balance and Function in Patients with Grade I and II Knee Osteoarthritis. The results shows that although conventional exercise program is effective in reducing knee pain, and increasing lower extremity muscle strength and range of motion, adding neuromuscular training (KBA) along with conventional exercise program in rehabilitation leads to higher improvement on balance and function in patient with knee grade I and II osteoarthritis. A positive effect has been observed in treating patients with both the interventions. The past research records are evident that therapists have determined individual effects of calisthenics and neuromuscular training for rehabilitation of Knee OA. The evidence for implementation of two protocols for rehabilitation of Knee OA is sparse. So the aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Calisthenic training, Neuromuscular training, Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Neither subjects nor the investigator who is assessing the patient are aware of the treatment assignment until the end of the study
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calisthenic Training
Arm Type
Experimental
Arm Description
Calisthenic Training Group
Arm Title
Neuromuscular Training Group
Arm Type
Experimental
Arm Description
Neuromuscular Training Group
Intervention Type
Other
Intervention Name(s)
Calisthenic Training
Other Intervention Name(s)
Group A
Intervention Description
Calisthenic Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises. Abductor-Adductor leg raise Alternate toe touch Knee Bend Prone leg extension Forward Lunges Toe Raise/ Calf raise Progressive training include following exercises. 1. Leg Lifts 2. Jack Twists 3. Side Lunges 4. Short bridge 5. Calf Raise with weight.
Intervention Type
Other
Intervention Name(s)
Neuromuscular Training
Other Intervention Name(s)
Group B
Intervention Description
Neuromuscular Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises. Up and down step exercise in posterior and lateral directions. Walking in anterior and posterior Directions with eyes opened and eyes closed. Walking in lateral direction with eyes opened and eyes closed. Standing on one extremity Inclination in anterior and lateral direction with eyes opened and closed. Progressive training includes following exercises. 1. Up and down on Bosu exercise. 2. Plantar flexion on minitrampoline. 3. Standing on one extremity on Bosu. 4. Standing on one extremity on minitrampoline
Primary Outcome Measure Information:
Title
WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index)
Description
Changes are measured from baseline. This test is used to measure physical function. The maximum score is 96 Higher the score the worst is pain, stiffness and physical function.
Time Frame
6 weeks
Title
NPRS(Numeric pain rating scale)
Description
Changes are measured from baseline. The test is used to measure pain. It score ranges from 0 to 10 with 0 indicating no pain and 10 is for pain as severe as possible
Time Frame
6 weeks
Title
Short Physical Performance Battery
Description
Changes are measured from baseline. The test is used to measure balance ,lower extremity strength and functional capacity with maximum score of 12. Score less than 10 indicates disability.
Time Frame
6 weeks
Title
Mini BES-Test
Description
Changes are measured from baseline. It is 36 items scales that evaluates Balance with total score of 28
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with chronic OA (symptoms for more than 3 months). Subjects willing to participate and take treatment. Grade of 2 to 3 as per Kellegren and Lawrence radiographic classification. Exclusion Criteria: Subjects having any systemic joint pathologies, inflammatory joint disease (e.g. Rheumatoid arthritis, gouty arthritis, psoriatic arthritis). Subjects who had any neurological deficit (paresthesia, sensory loss, radiculopathy, myelopathy any mental illness (Dementia, Alzheimer's, Parkinson disease etc.) that can affect orientation and concentration. Subjects on medication like antidepressants, corticosteroid, and anti-inflammatory medications. Peripheral vascular diseases. Any history of surgery related to lower extremity. Subjects having metal implants in the lower limb
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aruba Saeed, PhD*
Organizational Affiliation
Riphah International University
Official's Role
Study Chair
Facility Information:
Facility Name
Riphah International University
City
Rawalpindi
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Calisthenic and Neuromuscular Training in Patients With Knee OA.

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