Osteoarthritis, KneeNCT04099017
Mulligan Manual Therapy and Trunk Stabilization Exercises Versus Isometric Knee Strengthening on Knee Osteoarthritis
A study testing Mulligan Joint mobilization, Trunk stabilization group and Knee strengthening group in people with Osteoarthritis, Knee, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
Knee joint arthritis posses a serious health problem and caring for an individual with knee osteoarthritis (KOA) produces a great burden on society. Knee joint pain is associated with physical activity while performing various activities of daily living (ADL) in patients with early and severe osteoarthritis (OA). Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Mulligan Joint mobilization, Trunk stabilization group and Knee strengthening group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Sep 2020to 20 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- - Both gender (female and male) patients
- Age between 40 - 60
- Knee osteoarthritis Grade I \& II on Kellgren and Lawrence (K/L) criteria
- Prediagnosed case of knee OA as per the American College of Rheumatology (ACR).
Who cannot join
- Known skin allergies
- Sensory-motor dysfunction of lower extremity
- Severe joint deformity of lower extremity
- Post Traumatic Arthritis
- Constitutional Symptoms (Fever, Malaise, Weight Loss and high blood pressure)
- Knee Intraarticular injection in past 3 months
Show all 14Show fewer
- Acute low back pain
- History of spinal surgery
- Subject using assistive devices for ambulation i.e. cane, walkers, sticks
- Refused to give consent
- Body Mass Index > 30 kg/m2
- Received physiotherapy treatment in the past 3 months
- Visual Analogue Scale <4
- Patellofemoral joint arthritis will be excluded
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Dow University of Health Sciences & Institute of Physical Medicine and Rehabilitation
Karachi, Sindh, 74200
About this study
Official title: Effectiveness of Mulligan Joint Mobilizations and Trunk Stabilization Exercises Versus Isometric Knee Strengthening in the Management of Knee Osteoarthritis: a Randomized Controlled Trial
Knee joint arthritis posses a serious health problem and caring for an individual with knee osteoarthritis (KOA) produces a great burden on society. Knee joint pain is associated with physical activity while performing various activities of daily living (ADL) in patients with early and severe osteoarthritis (OA). In addition to knee pain, physical function or daily activity is strongly influenced by the severity of Osteoarthritis of the knee. Mulligan joint mobilization with movement provides evident effects on decreasing the pain and restoring the joint biomechanics. Trunk stabilization exercise will improve the stability of trunk which distributes the weight of body evenly on both feets. The aim of this study is to determine the effects of mulligan joint mobilization and trunk stabilization exercise on pain, disability and submaximal exercise performance in KOA.
Read the detailed description
A randomized control trial will be conducted at IPM\&R on 60 subjects with knee osteoarthritis and age between 40-60 years. Initial screening of the subjects will be carried out by the referring consultant. Subjects who fulfilled the study criteria will be recruited using computer generated random sampling after explaining the study objective and taken written informed consent. All participants will be evaluated using visual analogue scale, Knee injury and Osteoarthritis Outcome Score and 6-minute walk test for pain severity, functional limitation and submaximal exercise capacity at 1st, 3rd and 6th week. The subjects will be allocated into three groups through computer generated random allocation. Group 1 will receive mulligan mobilization with kinesiotaping and knee strengthening. Group 2 will receive trunk stabilization exercise, knee strengthening and Kinesiotaping. Group 3 will receive knee strengthening along with kinesiotaping. A drop-out rate of 9 will be taken. Recorded data will be entered and analysed using SPSS version 21. Mean and SD will be calculated of quantitative variables like age, pain, knee related function, submaximal exercise capacity and stair climb by using repeated measure ANOVA. For pair wise comparison, post hoc tukey will be applied. Value of equal to or less than 0.05 will be considered significant.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Mulligan Joint mobilization, Trunk stabilization group, Knee strengthening group
- Keywords
- manual therapy, kinesiotape, Excercise therapies, isometric contraction, muscle strength
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mulligan Joint mobilizationOther
This study ARM will received Mulligan joint mobilization and concomitant therapies in this group.
The following are the brief detail of therapy
- Mulligan joint mobilization in Non-weight bearing (NWB) to weight-bearing (WB) 6 -10 Reps and 3 sets/ session. Procedural detail: Joint mobilization will be performed in sagittal, frontal and transverse direction, following glide will be preferred will depend on patient adherence to the joint mobilization. Mobilization will be progress from NWB to WB according to patient compliance 27
- Knee strengthening Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks
- Kinesiotaping:
Trunk stabilization groupOther
This study ARM will received Trunk stabilization exercises and concomitant therapies in this group.
The following are the brief detail of therapy:
- Trunk stabilization Area: Trunk Type of exercise: Stabilization exercise Intensity: 6-8 reps Frequency: 3 sets per session and 30 second duration break between sets Procedural detail:
- modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge: Iv. lateral step up:
- Knee strengthening Area: Knee Joint Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks Procedural detail:
- Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise:
- Kinesiotaping:
Knee strengthening groupOther
This study ARM will received Knee strengthening exercises and concomitant therapies in this group.
The following are the brief detail of therapy:
- Knee strengthening Area: Knee Joint Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks Procedural detail:
- Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise:
- Kinesio-taping:
Muscle stretch method will be applied which involves one Y and two I straps: The Y-shaped tape base will be affixed over the top of patella then pulls up his/her knee to its maximum bending capacity then both end of Y strip is placed around the patella ending on the tibial tuberosity. Then reinforcing I-tape will be affixed at the origin and insertion of MCL and LCL. Tape will be change in every session.
| Study group | Role | What they receive |
|---|---|---|
| Mulligan mobilization group | Experimental | This study ARM will received Mulligan joint mobilization and concomitant therapies in this group.
The following are the brief detail of therapy
1. Mulligan joint mobilization in Non-weight bearing (NWB):
2. Knee strengthening
3. Kinesiotaping Receives: Other: Mulligan Joint mobilization |
| Trunk stabilization group | Experimental | This study ARM will received Trunk stabilization exercises and concomitant therapies in this group.
The following are the brief detail of therapy:
1. Trunk stabilization i. modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge:
Iv. lateral step up:
2. Knee strengthening i. Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise:
3. Kinesiotaping: Receives: Other: Trunk stabilization group |
| Knee strengthening group | Other | This study ARM will received Knee strengthening exercises and concomitant therapies in this group.
The following are the brief detail of therapy:
1. Knee strengthening i. Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise:
2. Kinesio-taping: Receives: Other: Knee strengthening group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint.
The KOOS contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sport and leisure activities and quality of life. A score of 0 (extreme problems) 100 (smoothly) can be obtained separately for each sub-range.
Measured: baseline and post intervention (week 6 - the analysis will be conducted on the first week immediately after the end of the training
Secondary outcomes (4)
Visual Analogue Scale
It measures the subjective of pain ranges from 10-cm lines with defined cut off scores. The correlation between vertical and horizontal orientations of the VAS is 0.99 . Aggregate score ranges for this screening tool starting with 0-10. Scores between 0-4 means mild pain. Scores between 4-7 indicates moderate pain. Scores between 7-10 means severe pain. pain severity will be assessed at rest and during stairs ascending and descending
Measured: baseline, 3 weeks and 6 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint.
The KOOS contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sport and leisure activities and quality of life. A score of 0 (extreme problems) 100 (smoothly) can be obtained separately for each sub-range.
Measured: baseline, 3 weeks and 6 weeks
6 Minute Walk Test
The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. Bright colour tapes will be used to mark the 12m walkway at each end. It will be ensured that the environment will be free from hazards and readings will be recorded by blind assessor. Participant will be instructed to wear comfortable shoes.
Measured: baseline, 3 weeks and 6 weeks
Stairs Climb Test
Stair climb test is used to measure the total time taken by the participant to ascend and descend stair onto with a step length of 16-cm (ICC=0.90). If safety is of concern, the assessor should guard behind the participant going up the stairs and to the side coming down the stairs. If there is no concern for safety, the tester should remain at the start/finish position on the ground landing
Measured: baseline, 3 weeks and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start20 Sep 2020
- Primary completion24 Feb 2021
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaikh Nabi Bukhsh Nazir, Dow University of Health Sciences
- Investigators
- SHAIKH NABI B NAZIR, MSAPT, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099017
- Sponsor's protocol ID
- IPM&R/DUHS-19/
- Status last verified
- May 2022
- First submitted
- 18 Sep 2019
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Nam CW, Park SI, Yong MS, Kim YM. Effects of the MWM Technique Accompanied by Trunk Stabilization Exercises on Pain and Physical Dysfunctions Caused by Degenerative Osteoarthritis. J Phys Ther Sci. 2013 Sep;25(9):1137-40. doi: 10.1589/jpts.25.1137. Epub 2013 Oct 20.
PubMed 24259931Nazir SNB, Rathore FA. Efficacy of Mulligan joint mobilizations and trunk stabilization exercises versus isometric knee strengthening in the management of knee osteoarthritis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 May 7;16(1):105. doi: 10.1186/s13102-024-00893-7.
PubMed 38715135
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mulligan Joint Mobilizations and Trunk Stabilization Exercises Versus Isometric Knee Strengthening in the Management of Knee Osteoarthritis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04099017
- Acronym / sponsor ID
- IPM&R/DUHS-19/
- Conditions
- Osteoarthritis, Knee
- Keywords
- manual therapy, kinesiotape, Excercise therapies, isometric contraction, muscle strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 23 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Knee joint arthritis posses a serious health problem and caring for an individual with knee osteoarthritis (KOA) produces a great burden on society. Knee joint pain is associated with physical activity while performing various activities of daily living (ADL) in patients with early and severe osteoarthritis (OA). In addition to knee pain, physical function or daily activity is strongly influenced by the severity of Osteoarthritis of the knee. Mulligan joint mobilization with movement provides evident effects on decreasing the pain and restoring the joint biomechanics. Trunk stabilization exercise will improve the stability of trunk which distributes the weight of body evenly on both feets. The aim of this study is to determine the effects of mulligan joint mobilization and trunk stabilization exercise on pain, disability and submaximal exercise performance in KOA.
Detailed description
A randomized control trial will be conducted at IPM\&R on 60 subjects with knee osteoarthritis and age between 40-60 years. Initial screening of the subjects will be carried out by the referring consultant. Subjects who fulfilled the study criteria will be recruited using computer generated random sampling after explaining the study objective and taken written informed consent. All participants will be evaluated using visual analogue scale, Knee injury and Osteoarthritis Outcome Score and 6-minute walk test for pain severity, functional limitation and submaximal exercise capacity at 1st, 3rd and 6th week. The subjects will be allocated into three groups through computer generated random allocation. Group 1 will receive mulligan mobilization with kinesiotaping and knee strengthening. Group 2 will receive trunk stabilization exercise, knee strengthening and Kinesiotaping. Group 3 will receive knee strengthening along with kinesiotaping. A drop-out rate of 9 will be taken. Recorded data will be entered and analysed using SPSS version 21. Mean and SD will be calculated of quantitative variables like age, pain, knee related function, submaximal exercise capacity and stair climb by using repeated measure ANOVA. For pair wise comparison, post hoc tukey will be applied. Value of equal to or less than 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mulligan mobilization group | Experimental | Other: Mulligan Joint mobilizationThis study ARM will received Mulligan joint mobilization and concomitant therapies in this group. The following are the brief detail of therapy 1. Mulligan joint mobilization in Non-weight bearing (NWB): 2. Knee strengthening 3. Kinesiotaping |
| Trunk stabilization group | Experimental | Other: Trunk stabilization groupThis study ARM will received Trunk stabilization exercises and concomitant therapies in this group. The following are the brief detail of therapy: 1. Trunk stabilization i. modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge: Iv. lateral step up: 2. Knee strengthening i. Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise: 3. Kinesiotaping: |
| Knee strengthening group | Other | Other: Knee strengthening groupThis study ARM will received Knee strengthening exercises and concomitant therapies in this group. The following are the brief detail of therapy: 1. Knee strengthening i. Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise: 2. Kinesio-taping: |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- - Both gender (female and male) patients
- Age between 40 - 60
- Knee osteoarthritis Grade I \& II on Kellgren and Lawrence (K/L) criteria
- Prediagnosed case of knee OA as per the American College of Rheumatology (ACR).
Key exclusion criteria (14 listed)
- Known skin allergies
- Sensory-motor dysfunction of lower extremity
- Severe joint deformity of lower extremity
- Post Traumatic Arthritis
- Constitutional Symptoms (Fever, Malaise, Weight Loss and high blood pressure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulligan Joint mobilizationThis study ARM will received Mulligan joint mobilization and concomitant therapies in this group. The following are the brief detail of therapy 1. Mulligan joint mobilization in Non-weight bearing (NWB) to weight-bearing (WB) 6 -10 Reps and 3 sets/ session. Procedural detail: Joint mobilization will be performed in sagittal, frontal and transverse direction, following glide will be preferred will depend on patient adherence to the joint mobilization. Mobilization will be progress from NWB to WB according to patient compliance 27 2. Knee strengthening Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks 3. Kinesiotaping: | Other | Mulligan mobilization group |
| Trunk stabilization groupThis study ARM will received Trunk stabilization exercises and concomitant therapies in this group. The following are the brief detail of therapy: 1. Trunk stabilization Area: Trunk Type of exercise: Stabilization exercise Intensity: 6-8 reps Frequency: 3 sets per session and 30 second duration break between sets Procedural detail: i. modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge: Iv. lateral step up: 2. Knee strengthening Area: Knee Joint Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks Procedural detail: i. Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise: 3. Kinesiotaping: | Other | Trunk stabilization group |
| Knee strengthening groupThis study ARM will received Knee strengthening exercises and concomitant therapies in this group. The following are the brief detail of therapy: 1. Knee strengthening Area: Knee Joint Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks Procedural detail: i. Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise: 2. Kinesio-taping: Muscle stretch method will be applied which involves one Y and two I straps: The Y-shaped tape base will be affixed over the top of patella then pulls up his/her knee to its maximum bending capacity then both end of Y strip is placed around the patella ending on the tibial tuberosity. Then reinforcing I-tape will be affixed at the origin and insertion of MCL and LCL. Tape will be change in every session. | Other | Knee strengthening group |
Primary outcome
Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks
Time frame: baseline and post intervention (week 6 - the analysis will be conducted on the first week immediately after the end of the training
The Knee injury and Osteoarthritis Outcome Score (KOOS) is a self reported specific joint measure developed to assess a broad spectrum of patients with knee injuries and OA, for pain and other symptoms, function in daily life, function in sports and recreation, and quality of knee-related life, being easy to use, evaluating the short- and long-term health problems related to the knee joint. The KOOS contains 42 items covering five subscales: pain, other symptoms, activities of daily living, sport and leisure activities and quality of life. A score of 0 (extreme problems) 100 (smoothly) can be obtained separately for each sub-range.
4 secondary outcomes
Visual Analogue Scale
Time frame: baseline, 3 weeks and 6 weeks
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: baseline, 3 weeks and 6 weeks
6 Minute Walk Test
Time frame: baseline, 3 weeks and 6 weeks
Stairs Climb Test
Time frame: baseline, 3 weeks and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Background: PubMed 24259931Nam CW, Park SI, Yong MS, Kim YM. Effects of the MWM Technique Accompanied by Trunk Stabilization Exercises on Pain and Physical Dysfunctions Caused by Degenerative Osteoarthritis. J Phys Ther Sci. 2013 Sep;25(9):1137-40. doi: 10.1589/jpts.25.1137. Epub 2013 Oct 20.
- Derived from this study: PubMed 38715135Nazir SNB, Rathore FA. Efficacy of Mulligan joint mobilizations and trunk stabilization exercises versus isometric knee strengthening in the management of knee osteoarthritis: a randomized controlled trial. BMC Sports Sci Med Rehabil. 2024 May 7;16(1):105. doi: 10.1186/s13102-024-00893-7.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SHAIKH NABI B NAZIR, MSAPT principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mulligan Joint mobilization, Trunk stabilization group and Knee strengthening group in people with Osteoarthritis, Knee, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS) at 6 weeks (time frame: baseline and post intervention (week 6 - the analysis will be conducted on the first week immediately after the end of the training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04099017, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022; AzTrials last refreshed its copy on 1 Nov 2026.