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current study who had been diagnosed with medial knee osteoarthritis; mean age 61.1 (9.4) years (age range 47-78 years), mean height 174.1 (8.5) cm (height range 161-191 cm), mean mass 83 (18.9) kg (mass range 51-119 kg), mean BMI 26.9 (4.8) kg/m²; BMI range 18.3-34.7 kg/m². The mean of EKAM, KAAI, number of daily steps, and knee pain at baseline in this study were 0.41 (0.13) Nm/kg, 2.42 (0.84) %Bw.ht, 0.26 (0.08) (Nm/kg).s, 6673 (3368) steps/day, 50.8 (13.5), respectively.

The EKAM at baseline in the current study is in agreement with Jones et al., (2013b & 2015), Al- Khlaifat et al., (2016) and Al-Zahrani et al., (2016) where EKAMs were 0.38 Nm/kg, 0.39 Nm/kg, 0.34 Nm/kg and 0.44Nm/kg, respectively, all these data were collected in the same gait laboratory. The data in the current study is similar in nature to the previously collected lab data. The EKAMs at baseline were lower in Chang et al., (2015) where the mean EKAM was 1.67 %Bw.ht. One of the potential reasons that the EKAM was lower is that the majority of individuals at baseline (70.3%) in Chang et al (2015) study (70.3%) were diagnosed with mild knee OA (K/L grade ≥ 2) and thereby

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EKAM was lower (Foroughi et al., 2009). Whereas, in the current study individuals with mild- moderate medial knee OA (K/L grade 2 or 3) were assessed. In Hinman et al., (2009) study, the EKAM at baseline was higher (3.82 %Bw.ht) compared to the current study, this may be because the magnitude of mean walking speed at baseline was higher in the Hinman et al (2009) study (1.27 m/s).

As expected, the Knee Adduction Angular Impulse (KAAI) at baseline in the current study is in agreement with of Jones et al., (2013b), Keen et al., (2015), Jones et al., (2015), Al-Khlaifat et al., (2016), and Al-Zahrani et al., (2016) where KAAIs were 0.15 (Nm/kg).s, 0.19 (Nm/kg).s, 0.16 (Nm/kg).s, 0.12 (Nm/kg).s, 0.14 (Nm/kg).s, respectively.

The average of number of steps, at the baseline assessment in the current study, is in agreement with a large observational study performed by White et al., (2015) where the mean number of steps was 6650 steps/day (±2741). In Bennell et al., (2011), the participants in both groups stepped further with 7735 steps/day (±3652) at the baseline. Moreover, a recent review of normative data reported that individuals with chronic disease that may limit mobility stepped between 1200 and 8800 steps/day (Tuder-Locke et al., 2009). Hurley et al., (2015) found that individuals with knee OA walked an average of 6518 steps/day which is in agreement with the current study. From a clinical perspective, the pain scale of the KOOS is slightly above the results in Al-Khlaifat et al., (2016), and Al-Zahrani et al., (2016) studies where pain in individuals with medial knee OA at baseline were 34,5 and 33.18, respectively. Whereas in Kumer et al (2013) KOOS pain was high (64.2) in individuals with medial knee OA compare to healthy subjects. This may be because the individuals with medial knee OA in Kumer et al., (2913) study had a higher EKAM at the first peak compared with healthy individuals.

Therefore, the baseline results of EKAM, KAAI, number of daily steps, and Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscale (primary outcomes) of this study are in agreement with the majority of the current literature. This allows us to set the results in context of this literature and be able to broaden the knowledge base in this area.

172 4.11.2.Summary of the results

The present study was undertaken to investigate the effect of lateral wedged insoles (LWI) on the EKAM, knee pain, and physical activity level in individuals with medial knee OA. The individuals were assessed in two different time points; one week after baseline assessment and six weeks after baseline assessment. There were no significantly differences between groups at baseline were found in participant demographic, EKAM, pain score, and level of activity. This allows the comparison between groups to be undertaken and the following will summarise the results, both at the different time points and between groups.

After one week of wearing insoles

After one week, the first peak of the EKAM was significantly reduced in the LWI group compared to the baseline and the comparator insole group whereas, the second peak of the EKAM significantly reduced in the LWI group compared to baseline but there was no significant difference between groups. The knee adduction angular impulse (KAAI) was reduced significantly in the LWI group only compared to baseline with no significant differences seen between groups. Over one week, knee pain significantly improved in both groups compared to the baseline but there was no significant difference between groups after using insoles.

There was no significant change within group and between-groups in terms of ground reaction force (GRF), cumulative knee loading (CKL), knee moment in sagittal plane, hip angle in sagittal plane, knee angle in sagittal plane, knee angle in frontal plane, ankle angle in sagittal plane. Whereas, range of motion (ROM) of the sagittal plane ankle angle was significantly increased in LWI group compared to baseline.

The temporal and spatial variables were improved in both groups after one week compared to baseline except stance time and cadence not improving in comparator group compared to baseline. Cadence was significantly increased in LWI group over one week compared with the comparator group. While, walking speed increased in LWI group compared with the comparator group but not significant.

After six week of wearing insole

After six weeks, the first peak of the EKAM was significantly reduced in the LWI group compared to the baseline and comparator group whereas, the second peak of the EKAM was significantly reduced in the LWI group compared to baseline but not between groups. Only in the LWI group was KAAI significantly reduced compared to the baseline and the comparator group after six weeks of using the LWI.

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After six weeks, there were no significant differences between-groups in terms of symptoms subscale, Activity of Daily Living (ADL) subscale, and Quality of Life (QoL) subscale over six weeks. Whereas, there was a significant improvement in LWI group compared to the comparator group over the six weeks in the sport & recreational subscale. However, when compared to baseline, the LWI group did show a significant reduction in symptoms and the sport & recreational subscales.

There was a significant improvement in the LWI group compared to the comparator group over the six weeks in terms of Aggregated Locomotor Function score (ALF), and anterior & medial directions of Star Excursion Balance Test (SEBT). ALF and the medial direction of SEBT were also significantly improved in the LWI group compared to baseline.

After six weeks, Intermittent and Constant Osteoarthritis Pain (ICOP) and Physical Component Scale (PCS) of 12-Items Short-Form Health Survey (SF-12) were improved significantly in both groups compared to baselines. Whereas, PCS of SF-12 significantly improved only in the LWI group compared to the comparator group

There were no significant changes within group or between-groups in terms of GRF, CKL, knee extension moment, hip angle in sagittal plane, knee angle in sagittal plane, knee angle in frontal plane, ankle angle in sagittal plane. Whereas, knee flexion moment, ROM of knee in sagittal plane and ankle dorsi-flexion angle were significantly increased in LWI group compared to the baseline.

The temporal and spatial variables were significantly increased in the LWI group over the six weeks compared to the baseline, except the unaffected step length did not change significantly. Speed, stride length, cadence and affected and unaffected step length were increased in comparator group compared to baseline whereas, affected and unaffected stance time did not change significantly. There was no significant change between groups after six weeks.

The results achieved in the study will now be contemporised in terms of where these fit with the current literature focussing on the specific hypotheses stated earlier in the thesis.

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