NCT05173649

Brief Summary

The aim of the study is to compare effects of calisthenics and neuromuscular training in patients with knee osteoarthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 18, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 30, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2022

Completed
Last Updated

April 18, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 18, 2021

Last Update Submit

April 15, 2022

Conditions

Keywords

Calisthenic trainingNeuromuscular trainingKnee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • 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.

    6 weeks

  • 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

    6 weeks

  • 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.

    6 weeks

  • Mini BES-Test

    Changes are measured from baseline. It is 36 items scales that evaluates Balance with total score of 28

    6 weeks

Study Arms (2)

Calisthenic Training

EXPERIMENTAL

Calisthenic Training Group

Other: Calisthenic TrainingOther: Neuromuscular Training

Neuromuscular Training Group

EXPERIMENTAL

Neuromuscular Training Group

Other: Calisthenic TrainingOther: Neuromuscular Training

Interventions

Calisthenic Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises. 1. Abductor-Adductor leg raise 2. Alternate toe touch 3. Knee Bend 4. Prone leg extension 5. Forward Lunges 6. 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.

Also known as: Group A
Calisthenic TrainingNeuromuscular Training Group

Neuromuscular Training Performed thrice a week after baseline assessment Standard Physical therapy treatment along with following exercises. 1. Up and down step exercise in posterior and lateral directions. 2. Walking in anterior and posterior 3. Directions with eyes opened and eyes closed. 4. Walking in lateral direction with eyes opened and eyes closed. 5. Standing on one extremity 6. 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

Also known as: Group B
Calisthenic TrainingNeuromuscular Training Group

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Aruba Saeed, PhD*

    Riphah International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Neither subjects nor the investigator who is assessing the patient are aware of the treatment assignment until the end of the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2021

First Posted

December 30, 2021

Study Start

November 11, 2021

Primary Completion

January 30, 2022

Study Completion

January 30, 2022

Last Updated

April 18, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations