What Are the Isokinetic Strength Outcomes and Self-reported Functional Outcomes (ATRS) at 12 Months Following Non-surgical Management of Achilles Tendon Rupture Using the SMART Protocol?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 115
- 试验地点
- 2
- 主要终点
- Isokinetic plantarflexor strength
研究概览
简要总结
Achilles tendon rupture is a common injury that can significantly impact strength, function, and quality of life. While non-surgical management using structured rehabilitation protocols such as the Swansea Morriston Achilles Rupture Treatment (SMART) protocol is increasingly adopted, there is limited evidence on long-term recovery outcomes, particularly beyond six months.
This study aims to evaluate recovery at 12-15 months following non-surgical management of Achilles tendon rupture in an NHS population. Participants will attend a single study visit during which plantarflexor muscle strength will be assessed using isokinetic dynamometry, and patient-reported outcomes will be collected using the Achilles Tendon Total Rupture Score (ATRS) and EQ-5D-5L questionnaire. Achilles Tendon Resting Angle (ATRA) will also be measured to provide an estimate of tendon elongation.
The primary objectives are to quantify plantarflexor strength recovery and self-reported functional outcomes. Secondary analyses will explore associations between strength, tendon elongation, quality of life, return to sport, and pre-injury symptoms.
This cross-sectional observational study will recruit adult patients managed non-surgically with the SMART protocol from Liverpool University Hospitals NHS Foundation Trust. Findings will provide clinically relevant data on long-term recovery following conservative treatment and may inform rehabilitation strategies and return-to-activity decision-making.
详细描述
This study is a cross-sectional observational investigation designed to evaluate objective and patient-reported recovery outcomes following non-surgical management of Achilles tendon rupture using the Swansea Morriston Achilles Rupture Treatment (SMART) rehabilitation protocol. The study is conducted within a National Health Service (NHS) setting at Liverpool University Hospitals NHS Foundation Trust.
Participants will be identified from an established clinical database of patients who have sustained an Achilles tendon rupture and completed non-operative rehabilitation. Eligible individuals will be invited to attend a single assessment session at 12-15 months post-injury. This time point has been selected to reflect longer-term recovery, as previous literature has predominantly focused on early and mid-term outcomes.
Study Procedures and Data Collection During the study visit, participants will undergo a comprehensive assessment including objective, clinical, and patient-reported measures. Isokinetic dynamometry will be used to quantify plantarflexor muscle performance under controlled conditions. Testing will be standardised, including participant positioning, joint alignment, range of motion, and angular velocities. Outcome variables will include peak torque and torque relative to body mass, allowing both within-participant and between-participant comparisons.
Achilles tendon structural characteristics will be assessed indirectly using the Achilles Tendon Resting Angle (ATRA), a clinically applicable proxy for tendon elongation. Measurements will be taken bilaterally using a standardised protocol with repeated trials to improve reliability, and side-to-side differences will be calculated.
Participants will also complete validated patient-reported outcome measures to capture functional status and general health. Additional contextual variables, including return-to-sport status and pre-injury Achilles symptoms, will be recorded to enable exploratory subgroup analyses.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older at the time of recruitment
- •Have a confirmed diagnosis of Achilles tendon rupture, diagnosed clinically and recorded within the NHS clinical database
- •Have been managed non-surgically using the SMART (Swansea Morriston Achilles Rupture Treatment) rehabilitation protocol
- •Be between 12 and 15 months post-injury at the time of study assessment
- •Be able and willing to provide written informed consent to participate in the study
排除标准
- •Unable to provide informed consent
- •Have previously undergone surgical repair of the Achilles tendon or experienced a re-rupture
- •Have a neuromuscular or neurological condition that could affect lower limb strength or function
- •Did not follow the SMART rehabilitation protocol for non-surgical management
- •Have a history of Achilles tendinopathy or rupture in the contralateral (uninjured) limb
- •Are unable to tolerate isokinetic strength testing due to pain, discomfort, or other medical reasons
研究组 & 干预措施
Non-Surgically Managed Achilles Tendon Rupture Cohort
Adults who sustained an Achilles tendon rupture and were managed non-surgically using the SMART rehabilitation protocol within Liverpool University Hospitals NHS Foundation Trust. All participants are 12-15 months post-injury at the time of assessment.
干预措施: Non-Surgical Management Using the SMART Protocol (Other)
结局指标
主要结局
Isokinetic plantarflexor strength
时间窗: 12-15 months post-injury (single study visit)
Peak torque (Nm): the maximum force produced by the calf muscles during a contraction * Peak torque normalised to bodyweight (Nm/kg): to allow comparison between individuals of different body sizes * Limb Symmetry Index (LSI): the strength of the injured limb expressed as a percentage of the uninjured limb
Achilles Tendon Total Rupture Score
时间窗: 12-15 months post-injury (single study visit)
The Achilles Tendon Total Rupture Score (ATRS) is a validated patient-reported outcome measure assessing symptoms, physical activity, and functional limitations following Achilles tendon rupture. Scores range from 0 to 100, with higher scores indicating better perceived recovery and fewer symptoms. Time Frame: 12-15 months post-injury (single study visit) Unit of Measure: Points Minimum Value: 0 Maximum Value: 100 Higher scores indicate: Better outcome (fewer symptoms and greater function) Lower scores indicate: Worse outcome (more symptoms and greater functional limitation)
Isokinetic plantarflexor strength - Peak Torque
时间窗: 12-15 months post-injury (single study visit)
Peak plantarflexion torque will be measured using isokinetic dynamometry. Peak torque (Newton metres \[Nm\]) represents the maximum force generated by the plantarflexor muscles during a maximal voluntary contraction. Unit of Measure: Newton metres (Nm) Minimum value: 0 Nm Maximum value: No fixed maximum value Higher values indicate: Greater plantarflexor muscle strength (better outcome)
Isokinetic Plantarflexion Strength Normalised to Body Weight
时间窗: 12-15 months post injury
Peak plantarflexion torque normalised to body weight, measured using isokinetic dynamometry. Results are expressed as Newton metres per kilogram (Nm/kg) to facilitate comparison of plantarflexor muscle strength between individuals of different body sizes. Unit of Measure: Newton metres per kilogram (Nm/kg) Minimum Value: 0 Nm/kg Maximum Value: No fixed maximum value Higher values indicate: Greater plantarflexor muscle strength relative to body weight (better outcome)
Isokinetic Plantarflexion Strength Limb Symmetry Index (LSI)
时间窗: 12-15 months post injury
Limb Symmetry Index (LSI) for isokinetic plantarflexion strength. LSI is calculated as the peak torque of the injured limb divided by the peak torque of the uninjured limb and expressed as a percentage. An LSI of 100% indicates equal strength between limbs, while values below 100% indicate a strength deficit in the injured limb. Unit of Measure: Percent (%) Minimum Value: 0% Maximum Value: No fixed maximum value Higher values indicate: Greater symmetry between injured and uninjured limbs and therefore a better outcome.
Peak Plantarflexion Torque (Nm)
时间窗: 12-15 months post-injury (single study visit)
Maximum rotational force produced by the plantarflexor muscles during an isokinetic concentric contraction, measured using an isokinetic dynamometer. This measure reflects calf muscle strength and tendon function following non-surgical Achilles tendon rupture management.
Peak Plantarflexion Torque Normalized to Bodyweight (Nm/kg)
时间窗: 12-15 months post-injury (single study visit)
Peak plantarflexion torque adjusted for each participant's bodyweight. Normalisation allows strength comparisons between individuals of different body sizes and provides a more functional evaluation of recovery.
Limb Symmetry Index (LSI) for Peak Torque (%)
时间窗: 12-15 months post-injury (single study visit)
Ratio of injured limb peak plantarflexion torque to the uninjured limb, expressed as a percentage. An LSI ≥90% is typically considered indicative of satisfactory recovery.
次要结局
- Pre-injury Achilles symptoms(12-15 months post injury)
- Correlation between isokinetic strength and ATRS(12-15 months post injury)
- Health-related quality of life(12-15 months post injury)
- Achilles Tendon Resting Angle(12-15 months post injury)
- Return to sport/activity status(12-15 months post injury)
- Correlation Between Achilles Tendon Total Rupture Score and Peak Plantarflexion Torque(12-15 months post injury)
- Correlation Between Achilles Tendon Total Rupture Score and Plantarflexion Strength Limb Symmetry Index(12-15 months post injury)
- Health-related quality of life - EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) Summed Dimension Score(12-15 months post injury)
- Health related quality of life - EuroQol Visual Analogue Scale(12-15 months post injury)
- Achilles Tendon Resting Angle (ATRA)(12-15 months post injury)
- Presence of Pre-Injury Achilles Tendon Symptoms(12-15 months post injury)
- Correlation Between Isokinetic Strength Measures and Achilles Tendon Total Rupture Score(12-15 months post-injury (single study visit))
研究者
Raymond Healy
Senior Physiotherapist
Liverpool University Hospitals NHS Foundation Trust