Hamstring ContracturesNCT04784741
Effect of Low Amplitude Vibration Therapy on Flexibility of Hamstring Muscle in Athletes of Pakistan
A study testing Conventional static hamstring muscle stretching, Low amplitude whole body vibration therapy and Biodex Balance System in people with Hamstring Contractures and Whole Body Vibration, run by Shifa Clinical Research Center at 1 site in Pakistan.
Trial summary
Whole body vibration therapy is rapidly becoming a topic of interest for the researchers around the world. Evidence suggests that Whole body vibration has an effect on improving flexibility of hamstring muscle and balance in athletes. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Hamstring Contractures, Whole Body Vibration
- What is being tested?
- Conventional static hamstring muscle stretching, Low amplitude whole body vibration therapy and Biodex Balance System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2017to 3 Jan 2018
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- National athletes of Pakistan.
- Age between 18-30 years
Who cannot join
- Athletes having history of any acute injury within last 6 weeks.
- Athletes who have had any surgical procedure previously or Patients who were medically unstable.
Trial locations and contacts
1 site in 1 country.
About this study
Whole body vibration therapy is rapidly becoming a topic of interest for the researchers around the world. Evidence suggests that Whole body vibration has an effect on improving flexibility of hamstring muscle and balance in athletes. The purpose was to examine the effect of low amplitude Whole body vibration on the flexibility of hamstring muscle and improving balance in athletes of Pakistan
Read the detailed description
A total 60 number of athletes were analyzed and out of these 40 were included in the study who full fill the inclusion criteria, selected athletes were randomly assigned into two groups (control \& experimental). After a total 2 drop outs from control group and 3 drop outs from experimental group, there were 18 athletes in control group and 17 in experimental group who continued till the analysis. Experimental group was given five sessions of low amplitude whole body vibration therapy for almost duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles for 5 minutes and the control group was given only the static hamstring muscle stretches for five minutes, and same five sessions alike on alternative days. Static stretching protocol had 10 stretches in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle. All participants were assessed using Biodex Whole body vibration plate, Biodex balance system , Goniometer and a questionnaire.
- Conditions
- Hamstring Contractures, Whole Body Vibration
- Being tested
- Conventional static hamstring muscle stretching, Low amplitude whole body vibration therapy, Biodex Balance System, Range of motion of hamstring muscle
- Keywords
- whole body vibration, Hamstring flexibility, ROM, Balance, Postural stability index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional static hamstring muscle stretchingOther
Static stretching protocol had 10 repetitions in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle.
Low amplitude whole body vibration therapyDevice
Given five sessions of low amplitude whole body vibration therapy for duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles.
Static stretching protocol had 10 repetitions in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle.
Biodex Balance SystemDevice
Pre and post balance assessment by Biodex balance system
Range of motion of hamstring muscleProcedure or surgery
Straight Leg Raising to check pre and post Range of Motion by using Goniometer
| Study group | Role | What they receive |
|---|---|---|
| Control group | Other | The control group was given the static hamstring muscle stretches, five sessions on alternative days according to the set protocols. Receives: Other: Conventional static hamstring muscle stretching; Device: Biodex Balance System; Procedure: Range of motion of hamstring muscle |
| Experimental Group | Experimental | Given five sessions of low amplitude whole body vibration therapy for duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles. Receives: Device: Low amplitude whole body vibration therapy; Device: Biodex Balance System; Procedure: Range of motion of hamstring muscle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre Range of Motion of hamstring muscle (ROM)
The outcome was the pre status of flexibility in hamstring muscle assessed using Goniometer.
Measured: outcome at baseline (day zero)
Post Range of Motion of hamstring muscle (ROM)
The outcome was the post status of flexibility in hamstring muscle assessed using Goniometer.
Measured: outcome at the end of 10 days
Pre Balance
The outcome was pre balance testing using biodex balance system.
Measured: outcome at baseline (day zero)
Post Balance
The outcome was post balance testing using biodex balance system.
Measured: outcome at the end of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start5 Aug 2017
- Primary completion7 Nov 2017
- Study completion3 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hamstring ContracturesStudies 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
- Model description
- A total of 40 were included in the study who full filled the inclusion criteria, athletes were randomly assigned into two groups: Control and Experimental group. Additionally, data was collected from healthy athletes doing their training at Pakistan Sports Board, Islamabad.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shifa Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jaweria Syed, Shifa Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784741
- Sponsor's protocol ID
- Riphah/RCRS/REC/00255
- Status last verified
- Mar 2021
- First submitted
- 2 Mar 2021
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Amplitude Vibration Therapy on Flexibility of Hamstring Muscle in Athletes of Pakistan
- ClinicalTrials.gov ID
- NCT04784741
- Acronym / sponsor ID
- Riphah/RCRS/REC/00255
- Conditions
- Hamstring Contractures, Whole Body Vibration
- Keywords
- whole body vibration, Hamstring flexibility, ROM, Balance, Postural stability index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shifa Clinical Research CenterUniversity, hospital or other
- Study start
- 5 Aug 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 3 Jan 2018 (actual)
- First posted
- 5 Mar 2021 (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.
Whole body vibration therapy is rapidly becoming a topic of interest for the researchers around the world. Evidence suggests that Whole body vibration has an effect on improving flexibility of hamstring muscle and balance in athletes. The purpose was to examine the effect of low amplitude Whole body vibration on the flexibility of hamstring muscle and improving balance in athletes of Pakistan
Detailed description
A total 60 number of athletes were analyzed and out of these 40 were included in the study who full fill the inclusion criteria, selected athletes were randomly assigned into two groups (control \& experimental). After a total 2 drop outs from control group and 3 drop outs from experimental group, there were 18 athletes in control group and 17 in experimental group who continued till the analysis. Experimental group was given five sessions of low amplitude whole body vibration therapy for almost duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles for 5 minutes and the control group was given only the static hamstring muscle stretches for five minutes, and same five sessions alike on alternative days. Static stretching protocol had 10 stretches in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle. All participants were assessed using Biodex Whole body vibration plate, Biodex balance system , Goniometer and a questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 40 were included in the study who full filled the inclusion criteria, athletes were randomly assigned into two groups: Control and Experimental group. Additionally, data was collected from healthy athletes doing their training at Pakistan Sports Board, Islamabad.
| Arm | Type | Receives |
|---|---|---|
| Control group | Other | Other: Conventional static hamstring muscle stretching, Device: Biodex Balance System, Procedure: Range of motion of hamstring muscleThe control group was given the static hamstring muscle stretches, five sessions on alternative days according to the set protocols. |
| Experimental Group | Experimental | Device: Low amplitude whole body vibration therapy, Device: Biodex Balance System, Procedure: Range of motion of hamstring muscleGiven five sessions of low amplitude whole body vibration therapy for duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- National athletes of Pakistan.
- Age between 18-30 years
Key exclusion criteria (2 listed)
- Athletes having history of any acute injury within last 6 weeks.
- Athletes who have had any surgical procedure previously or Patients who were medically unstable.
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 |
|---|---|---|
| Conventional static hamstring muscle stretchingStatic stretching protocol had 10 repetitions in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle. | Other | Control group |
| Low amplitude whole body vibration therapyGiven five sessions of low amplitude whole body vibration therapy for duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles. Static stretching protocol had 10 repetitions in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle. | Device | Experimental Group |
| Biodex Balance SystemPre and post balance assessment by Biodex balance system | Device | Control group, Experimental Group |
| Range of motion of hamstring muscleStraight Leg Raising to check pre and post Range of Motion by using Goniometer | Procedure or surgery | Control group, Experimental Group |
Primary outcome
Pre Range of Motion of hamstring muscle (ROM)
Time frame: outcome at baseline (day zero)
The outcome was the pre status of flexibility in hamstring muscle assessed using Goniometer.
Post Range of Motion of hamstring muscle (ROM)
Time frame: outcome at the end of 10 days
The outcome was the post status of flexibility in hamstring muscle assessed using Goniometer.
Pre Balance
Time frame: outcome at baseline (day zero)
The outcome was pre balance testing using biodex balance system.
Post Balance
Time frame: outcome at the end of 10 days
The outcome was post balance testing using biodex balance system.
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 5 Mar 2021.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional static hamstring muscle stretching, Low amplitude whole body vibration therapy and Biodex Balance System in people with Hamstring Contractures and Whole Body Vibration, run by Shifa Clinical Research Center 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 2 inclusion and 2 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 5 Mar 2021. 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?
Pre Range of Motion of hamstring muscle (ROM) (time frame: outcome at baseline (day zero)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2021.