Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001243606
Ethics application status
Approved
Date submitted
20/10/2023
Date registered
1/12/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
1/12/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of manual therapy on ankle dorsiflexion range of motion: A pilot crossover randomised trial
Scientific title
The effect of ankle joint mobilisation and calf muscle massage on ankle joint dorsiflexion range of motion in individuals with restricted ankle dorsiflexion: A pilot crossover randomised trial
Secondary ID [1] 310831 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Restricted ankle dorsiflexion 331830 0
Condition category
Condition code
Musculoskeletal 328569 328569 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Passive accessory mobilisation of the ankle joint

Materials: treatment plinth, stop watch.

Procedures: Participants were randomised to receive ankle joint mobilisation in the first session and calf massage in the second session, or calf massage in the first session and ankle joint mobilisation in the second session. Attendance at both sessions was confirmed by an attendance checklist. There was a washout period of one to two weeks between intervention sessions.

At each session, ankle dorsiflexion ROM for both ankles was measured pre- and post-intervention. Passive accessory mobilisation was applied to both ankles. Participants sat in a reclined supine position with their foot over the end of the plinth and the therapist applied a rhythmic mobilisation to the talocrural joint in a posterior to anterior direction. For subtalar mobilisation, the participant laid on one side with the lateral aspect of the ankle uppermost at the edge of the plinth. A medial glide of the calcaneus with respect to the talus was applied. The participant then laid on their other side with the medial aspect of the ankle uppermost and a lateral glide of the calcaneus was applied with respect to the talus. Grade III mobilisations were applied to joints and in directions of stiffness (hypomobility). Grade II mobilisations were applied to joints where no restriction was felt, or joints were hypermobile. The intervention consisted of 2-4 sets of 30 seconds each at approximately one mobilisation per second, with an interval of 10 seconds between sets. For hypermobile joints, 2 sets of 30 seconds using a Grade II was applied and for restricted joints, 3-4 sets of 30 seconds using a Grade III was applied. Time for the intervention was 5 minutes.

Who: The manual therapy interventions were performed by a physiotherapist with more than 20 years of musculoskeletal physiotherapy experience.

Mode of delivery: In person / face-to face

Number of times: a single session.

Location: Laboratory setting at a regional Australian university.
Intervention code [1] 327241 0
Treatment: Other
Comparator / control treatment
Soft tissue massage of the calf muscle

Materials: Treatment plinth, towel, massage cream, stop watch.

Procedures: Participants were randomised to receive ankle joint mobilisation in the first session and calf massage in the second session, or calf massage in the first session and ankle joint mobilisation in the second session. Attendance at both sessions was confirmed by an attendance checklist. There was a washout period of one to two weeks between intervention sessions.

At each session, ankle dorsiflexion ROM for both ankles was measured pre- and post-intervention. Soft tissue massage was applied to both calf muscles. The participant laid prone on the treatment table and the manual therapist applied soft tissue massage techniques of effleurage, kneading and stroking to the calf muscles in a standardised manner. Care was taken to apply consistent manual therapy interventions with regard to the sequence of massage movements and the forces applied. To target the gastrocnemius muscles, the knee was positioned in a relatively extended position with a rolled towel placed under the foot and the soleus was targeted by bending the knee to approximately 90 degrees. Time for the calf muscle massage was 5 minutes.

Who: The manual therapy interventions were performed by a physiotherapist with more than 20 years of musculoskeletal physiotherapy experience.

Mode of delivery: In person / face-to face.

Number of times: a single session.

Location: Laboratory setting at a regional Australian university.
Control group
Active

Outcomes
Primary outcome [1] 336376 0
Ankle dorsiflexion range of motion
Timepoint [1] 336376 0
Baseline / pre-intervention 1 (t1), immediate post-intervention 1 (t2), pre-intervention 2 (t3) and immediate post-intervention 2 (t4)
Secondary outcome [1] 428097 0
Effectiveness of the washout period
Timepoint [1] 428097 0
Pre-intervention 1 (t1) to 7-14 days post-intervention 2 (t3)

Eligibility
Key inclusion criteria
Participants were eligible if they were adults between the age of 18 and 65 years of age, fluent in English, and had a previous lower limb injury, including ankle sprains and fractures. There were no limitations placed on the type or severity of injury.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria were: if there was a lower leg soft tissue injury within the last 3 months, a lower limb fracture within the previous 12 months, or if they had pins, plates or screws in situ as a result of a lower limb fracture, if participants were taking antithrombotic medication, had a lower limb neurological condition that caused a loss of sensation or were allergic to low-allergy massage cream.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All eligible participants were randomly allocated by an independent researcher into one of two groups. A coded randomisation table was created by the flip of a coin and was provided to the manual therapist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
All data were analyzed using IBM SPSS (Version 26) (IBM, N.Y.). Statistical analysis was conducted by grouping ankles into restricted and non-restricted; the ankle with the least dorsiflexion was considered restricted. The data were assessed for normality via the Shapiro-Wilks test. For normally distributed data, means and standard deviations were analysed. For skewed data, medians and interquartile range were analysed and for categorical data, frequencies and percentages. Mean range of motion change scores between the pre- and post-assessments for both groups were calculated. Paired t-tests were used to analyse the differences between change scores for both interventions, and differences between interventions. Effect size was calculated by the formula: mean difference divided by the pooled standard deviation (d=MD/SDpooled). Minimal detectable difference 95% (MDD95) was calculated using the formula MDD95 = 1.96 x v2 x SEM. The effectiveness of the washout period was analysed by comparing the first pre-intervention results (T1) with the second pre-intervention results (T3) using Wilcoxon signed ranks tests. Significance was set at p<0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
16/08/2017
Date of last participant enrolment
Anticipated
Actual
5/10/2018
Date of last data collection
Anticipated
Actual
12/10/2018
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 41578 0
3550 - Flora Hill

Funding & Sponsors
Funding source category [1] 314989 0
University
Name [1] 314989 0
La Trobe University
Country [1] 314989 0
Australia
Primary sponsor type
Individual
Name
Dr Carolyn Taylor
Address
PO Box 199, Bendigo, Victoria 3550
Country
Australia
Secondary sponsor category [1] 317096 0
None
Name [1] 317096 0
Address [1] 317096 0
Country [1] 317096 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313962 0
La Trobe College of SHE Human Ethics Committee
Ethics committee address [1] 313962 0
Ethics committee country [1] 313962 0
Australia
Date submitted for ethics approval [1] 313962 0
16/05/2017
Approval date [1] 313962 0
04/08/2017
Ethics approval number [1] 313962 0
HEC17/046

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129934 0
Dr Carolyn Taylor
Address 129934 0
La Trobe University, PO Box 199, Bendigo, Victoria 3550
Country 129934 0
Australia
Phone 129934 0
+61 417034350
Fax 129934 0
Email 129934 0
[email protected]
Contact person for public queries
Name 129935 0
Carolyn Taylor
Address 129935 0
La Trobe University, PO Box 199, Bendigo, Victoria 3550
Country 129935 0
Australia
Phone 129935 0
+61 417034350
Fax 129935 0
Email 129935 0
[email protected]
Contact person for scientific queries
Name 129936 0
Carolyn Taylor
Address 129936 0
La Trobe University, PO Box 199, Bendigo, Victoria 3550
Country 129936 0
Australia
Phone 129936 0
+61 417034350
Fax 129936 0
Email 129936 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethics approval does not allow


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of manual therapy on ankle dorsiflexion range of motion: A pilot crossover randomized trial.2024https://dx.doi.org/10.1016/j.jbmt.2023.11.027
N.B. These documents automatically identified may not have been verified by the study sponsor.