Calisthenic and Neuromuscular Training in Patients With Knee OA.

Sponsor

Riphah International University (Other)

Overall Status

Completed

CT.gov ID

NCT05173649

Collaborator

(none)

Enrollment

Location

Arms

2.6

Actual Duration (Months)

13.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Other: Calisthenic Training Other: Neuromuscular Training	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes 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

Primary Purpose:

Treatment

Official Title:

Effect of Calisthenics and Neuromuscular Training in Patients With Knee Osteoarthritis.

Actual Study Start Date :

Nov 11, 2021

Actual Primary Completion Date :

Jan 30, 2022

Actual Study Completion Date :

Jan 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Calisthenic Training Calisthenic Training Group	Other: Calisthenic Training 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. Other Names: Group A Other: Neuromuscular Training 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 Other Names: Group B
Experimental: Neuromuscular Training Group Neuromuscular Training Group	Other: Calisthenic Training 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. Other Names: Group A Other: Neuromuscular Training 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 Other Names: Group B

Arm

Intervention/Treatment

Experimental: Calisthenic Training

Calisthenic Training Group

Other: Calisthenic Training

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.

Other Names:

Group A

Other: Neuromuscular Training

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

Other Names:

Group B

Experimental: Neuromuscular Training Group

Neuromuscular Training Group

Other: Calisthenic Training

Other Names:

Group A

Other: Neuromuscular Training

Other Names:

Group B

Outcome Measures

Primary Outcome Measures

WOMAC(Western Ontario and McMaster Universities Osteoarthritis Index) [6 weeks]
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) [6 weeks]
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 [6 weeks]
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 [6 weeks]
Changes are measured from baseline. It is 36 items scales that evaluates Balance with total score of 28

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Riphah International University	Rawalpindi	Punjab	Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

Study Chair: Aruba Saeed, PhD*, Riphah International University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Riphah International University

ClinicalTrials.gov Identifier:

NCT05173649

Other Study ID Numbers:

REC/00956 Tayyeba Majid

First Posted:

Dec 30, 2021

Last Update Posted:

Apr 18, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Riphah International University

Calisthenic training

Neuromuscular training

Knee Osteoarthritis

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Apr 18, 2022